[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Children's Oncology Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":655},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,41,70,93,114,138,160,183,210,231,255,304,327,354,381,403,432,456,476,497,518,538,564,602,631],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100628797","phase-3-a-study-comparing-higher-dose-chemotherapy-over-a-shorter-amount-of-time-to-lower-dose-chemotherapy-plus-maintenance-over-a-longer-amount-of-time-in-patients-with-newly-diagnosed-intermediate-risk-rhabdomyosarcoma-ir-rms-100628797",false,"NCT07466316","A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)","A Randomized Phase 3 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) Versus VAC\u002FVI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma","Inclusion Criteria:\n\n* Patient must be ≤ 50 years of age at the time of enrollment\n* Patients with newly diagnosed soft tissue RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon FOXO1 fusion status, Stage, Intergroup Rhabdomyosarcoma Study (IRS) group, and age, as below. FOXO1 fusion status must be determined prior to enrollment. RMS types included under embryonal rhabdomyosarcoma (ERMS) include those which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (typical, dense and botryoid variants) and spindle cell\u002Fsclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Classification of alveolar Rhabdomyosarcoma (ARMS) in the 2020 WHO Classification is the same as in the International Classification of Rhabdomyosarcoma (ICR) and includes classic and solid variants.\n\n  * FOXO1 fusion negative (FN)\n\n    * Stage 2\u002F3, Group III\n    * Stage 4, Group IV, \\\u003C 10 years old\n  * FOXO1 fusion positive (FP)\n\n    * Stages 1-3, Groups I-III\n  * Disease\u002Fstaging imaging studies, if applicable, must be obtained within 21 days prior to enrollment and start of protocol therapy (repeat if necessary)\n* FOXO1 status results must be available to enroll. All patients will undergo institutional pathology review and institutional FOXO1 fusion determination regardless of histology prior to enrollment. FOXO1 status may confirmed by cytogenetic, fluorescence in situ hybridization (FISH), or next generation sequencing techniques. FOXO1 fusion results should be SUBMITTED as an upload to RAVE at study enrollment because this information is required for randomization.\n\nPlease note the following:\n\n* Institutional PAX3 versus (vs.) PAX7 determination is not required but should be submitted if available. Institutional FOXO1 testing may be performed at a contract or commercial lab as long as reports can be submitted and uploaded to RAVE. Additional molecular pathology reports, including the MCI report, are not required but should be submitted if available.\n* Patients who are \\\u003C 10 years old with distant metastatic disease (Stage 4) who have institutional molecular testing indicating fusion negative (FN) RMS but are later found to have fusion positive (FP) RMS by MCI or other testing will be considered to have metastatic FP disease and will go off study\n\n  * Appropriate lymph node sampling based on primary site of disease is required\n  * Patients must have a performance status of Lansky performance status score ≥ 50 for patients ≤ 16 years of age or Karnofsky performance status score ≥ 50 for patients \\> 16 years of age\n  * Peripheral absolute neutrophil count (ANC) ≥ 750\u002FμL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n  * Platelet count ≥ 75,000\u002FμL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n  * For pediatric patients \\\u003C 18 years of age:\n* A serum creatinine based on age\u002Fsex as follows:\n\n  * 1 month to \\\u003C 6 months: Maximum serum creatinine 0.4 mg\u002FdL (male), 0.4 mg\u002FdL (female)\n  * 6 months to \\\u003C 1 year: Maximum serum creatinine 0.5 mg\u002FdL (male), 0.5 mg\u002FdL (female)\n  * 1 to \\\u003C 2 years: Maximum serum creatinine 0.6 mg\u002FdL (male), 0.6 mg\u002FdL (female)\n  * 2 to \\\u003C 6 years: Maximum serum creatinine 0.8 mg\u002FdL (male), 0.8 mg\u002FdL (female)\n  * 6 to \\\u003C 10 years: Maximum serum creatinine 1 mg\u002FdL (male), 1 mg\u002FdL (female)\n  * 10 to \\\u003C 13 years: Maximum serum creatinine 1.2 mg\u002FdL (male), 1.2 mg\u002FdL (female)\n  * 13 to \\\u003C 16 years: Maximum serum creatinine 1.5 mg\u002FdL (male), 1.4 mg\u002FdL (female)\n  * ≥ 16 years: Maximum serum creatinine 1.7 mg\u002FdL (male),1.4 mg\u002FdL (female)\n* OR a 24-hour urine Creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m\\^2\n* OR a glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard).\n\n  * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility.\n* Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible. However, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (ie, percutaneous nephrostomies or ureteric stents) of the urinary tract.\n\nFor adult patients (aged 18 years or older):\n\n* Creatinine clearance ≥ 50 mL\u002Fmin, as estimated by the Cockcroft and Gault formula or as a 24-hour urine collection. Estimated creatinine clearance is based on actual body weight.\n\n(All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n\n  * If there is evidence of biliary obstruction by tumor, then total bilirubin must be \\\u003C 3 x ULN for age\n* Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) ≤ 135 U\u002FL (All laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory studies must be repeated prior to the start of protocol therapy if \\> 7 days have elapsed from their most recent prior assessment. Laboratory tests need not be repeated if therapy starts within seven (7) days of their most recent prior assessment. If the result of a laboratory study that is repeated at any time post-enrollment and prior to the start of protocol therapy is outside the limits for eligibility, then the evaluation must be rechecked within 48 hours prior to initiating protocol therapy. The results of the recheck must be within the limits for eligibility to proceed. If the result of the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL.\n* Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n\nExclusion Criteria:\n\n* Patients with evidence of uncontrolled infection are not eligible\n* Previous or concurrent cancer(s) that is\u002Fwas being treated with chemotherapy and\u002For radiation.\n\n  * Note: Surgical resection alone of previous or concurrent cancer(s) is allowed\n* Patients with central nervous system involvement of RMS as defined below:\n\n  * Malignant cells detected in cerebrospinal fluid\n  * Intra-parenchymal brain metastases separate and distinct from primary tumor (i.e., direct extension from parameningeal primary tumors is allowed)\n  * Diffuse leptomeningeal disease\n* Patients with known Charcot-Marie-Tooth disease\n* Patients who have received any chemotherapy (excluding steroids) and\u002For radiation therapy for RMS prior to enrollment. Note: the following exception:\n\n  * Patients requiring emergency radiation therapy for life-threatening complications of tumor burden due to RMS. These patients are eligible, provided they are consented to ARST2531 prior to administration of radiation.\n  * Note: Patients who have received or are receiving chemotherapy or radiation for non-malignant conditions (eg, autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation","ALL","50 Years",{"count":20,"type":21},342,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This phase III trial compares higher dose chemotherapy, with vincristine, dactinomycin and cyclophosphamide, over a shorter amount of time to lower dose chemotherapy plus maintenance, with vincristine, dactinomycin, cyclophosphamide, irinotecan and vinorelbine, over a longer amount of time, along with standard of care surgery and radiation, in patients with newly diagnosed intermediate risk rhabdomyosarcoma. Vincristine and vinorelbine are in a class of medications called vinca alkaloids. They work by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill tumor cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. It is not yet known if the higher dose chemotherapy over a shorter amount of time or the lower dose chemotherapy with maintenance over a longer amount of time is more effective in the treatment of patient with newly diagnosed, intermediate risk rhabdomyosarcoma.",[27],"Rhabdomyosarcoma","RECRUITING","2026-08-19",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":32},"2026-07-14",{"date":36,"type":21},"2031-03-31",{"name":38,"class":39},"Children's Oncology Group","NETWORK",85,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100598522","phase-2-testing-the-addition-of-daratumumab-to-chemotherapy-for-treating-patients-with-newly-diagnosed-t-cell-lymphoblastic-leukemia-t-all-and-t-cell-lymphoblastic-lymphoma-t-ll-100598522","NCT07072585","Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)","A Phase 2\u002F3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrolled on AALL2331.\n* Patients must be \\> 365 days and \\\u003C 21 years of age at the time of diagnosis.\n* \\* Newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-lineage lymphoblastic lymphoma (T-LL) stages II-IV.\n\n  * Note: A diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (CD19\u002FCD22\u002FCD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a, and are present either in peripheral blood or \\> 25% in the bone marrow. If surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including TdT, CD34 or CD99 will be assessed for expression. Cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory.\n  * For T-LL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL. For tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LL defined by the submitting institution will be accepted.\n\nExclusion Criteria:\n\n* Diagnosis of Down syndrome (trisomy 21).\n* Patients with known Charcot-Marie-Tooth disease.\n* \\* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-LL or for any cancer diagnosis prior to the initiation of protocol therapy on AALL2331 with the exception of:\n\n  * Steroid pretreatment: Prednisone or methylprednisolone for ≤ 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for ≤ 336 hours (14 days) in the 28 days prior to initiation of protocol therapy does not affect eligibility.\n  * Intrathecal cytarabine; or\n  * Pretreatment with hydroxyurea; or\n  * 600 cGy of chest irradiation, if medically necessary.\n  * Pre-treatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during sedation to prevent or treat airway edema. Patients who receive a single dose of dexamethasone to prevent or treat airway edema in the 28 days preceding diagnosis are eligible for this study.\n* \\* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n\n  * Lactating females who plan to breastfeed their infants.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.\n* Known severe persistent asthma anytime in the previous two years or uncontrolled asthma of any classification.\n* Peripheral neurotoxicity: Pre-existing ≥ grade 2 sensory or motor peripheral neurotoxicity.\n* Seizure disorder: Patients must not have an uncontrolled seizure disorder. Patients with a seizure history or a controlled seizure disorder are eligible. A controlled seizure disorder is defined as having stable or decreasing symptoms over the past 3 months without anti-epileptic medications or is on a stable or decreasing dose of anti-epileptic medication.\n* \\* Patients who are previously known to be seropositive for HIV except for HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment on this trial.\n\n  * Patients with evidence of chronic hepatitis B (HBV) infection, except for patients who have an HBV viral load that is undetectable on suppressive therapy.\n  * Patients with a history of hepatitis C virus (HCV) infection, except for those patients who have been treated and cured, or patients who are currently on HCV treatment who have an undetectable HCV viral load.\n* Patients with significant hepatic dysfunction defined as those with an alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) \\> 10x upper limit of normal (ULN) or direct bilirubin \\> 2x ULN unless the patient has known Gilbert's syndrome or has hepatic involvement from leukemic or lymphomatous infiltration.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.","365 Days","21 Years",{"count":51,"type":21},1708,[53,24],"PHASE2","This phase II\u002FIII trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.",[56,57,58,59,60],"Stage II T Lymphoblastic Leukemia\u002FLymphoma","Stage III T Lymphoblastic Leukemia\u002FLymphoma","Stage IV T Lymphoblastic Leukemia\u002FLymphoma","T Acute Lymphoblastic Leukemia","T Lymphoblastic Lymphoma","NOT_YET_RECRUITING","2026-07-29",{"date":64,"type":32},"2026-07-30",{"date":66,"type":21},"2026-08-28",{"date":68,"type":21},"2035-09-01",{"name":38,"class":39},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100493467","a-study-about-how-blood-cell-growth-patterns-relate-to-heart-health-after-treatment-for-hodgkin-lymphoma-100493467","NCT05705531","A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma","Assessment of Clonal Hematopoiesis and Its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors","Inclusion Criteria:\n\n* Patient must be \\>= 7 years of age at the time of enrollment (age to perform an MRI without sedation).\n* History of pathologically confirmed classical Hodgkin Lymphoma (cHL) initially diagnosed when the patient was \\>= 2 and \\\u003C 22 years of age.\n* As part of frontline therapy for cHL, the patient must have received a cumulative doxorubicin equivalent anthracycline dose of ≥ 200 mg\u002Fm\\^2 as estimated in doxorubicin isotoxic equivalents dose conversion calculation.\n\n  * Note: History of COG therapeutic trial participation is not required. Institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) can be used as reference documentation of receipt of anthracycline dose.\n* All systemic cancer treatment must have been completed ≥ 2 years prior to study enrollment.\n* Not known to have had a primary event (relapse\u002Fsecond malignancy\u002Fdeath).\n\n  * Note: Subjects treated at another institution are eligible if they are now being followed at the current COG institution, if the study procedures can be performed and the data accessible by a COG institution where the study is open.\n* Patient must have access to cardiac MRI at the enrolling institution and must be able to complete cardiac MRI without sedation.\n\nExclusion Criteria:\n\n* Medical contraindication to undergoing a non-contrast cardiac MRI.\n* Patients with nodular lymphocyte-predominant HL.\n* Received cancer therapy in addition to that for primary Hodgkin Disease (e.g., for disease progression or recurrence, or subsequent malignant neoplasm).\n* History of CTCAE grade 3 or higher cardiovascular disease or condition known to exist prior to the patient's initial diagnosis of cHL.\n\n  * Note: exceptions are made for congenital conditions considered fully resolved by surgery and chronic conditions such as hypertension or hypercholesterolemia that are managed with medical intervention.\n* History of an immunodeficiency that existed prior to cHL diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and conditions requiring systemic immunosuppressive agents.","7 Years",{"count":79,"type":21},190,"OBSERVATIONAL","This study assesses how blood cell growth patterns (clonal hematopoiesis) relate to heart health or cardiovascular disease (CVD) after treatment in patients with Hodgkin lymphoma. In some patients, cancer treatment at a young age may lead to later complications, including problems with heart health. Checking for blood cell growth patterns called therapy-related clonal hematopoiesis (t-CH) can help predict who might be at risk for heart health problems after Hodgkin lymphoma treatment. If doctors know who may be at greater risk for developing later heart complications, then they can more closely monitor those patients to prevent or detect heart complications early.",[83,84,85],"Cardiovascular Disorder","Classic Hodgkin Lymphoma","Clonal Hematopoiesis",{"date":64,"type":32},{"date":88,"type":32},"2023-08-18",{"date":90,"type":21},"2028-10-01",{"name":38,"class":39},36,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":49,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100385042","phase-3-a-study-to-compare-standard-chemotherapy-to-therapy-with-cpx-351-andor-gilteritinib-for-patients-with-newly-diagnosed-aml-with-or-without-flt3-mutations-100385042","NCT04293562","A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and\u002For Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations","A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831\n* Patients must be less than 22 years of age at the time of study enrollment\n* Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease\n\n  * Patient must have 1 of the following:\n\n    * \\>= 20% bone marrow blasts (obtained within 14 days prior to enrollment)\n\n      * In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy\n    * \\\u003C 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood\u002Fyoung adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)\n    * A complete blood count (CBC) documenting the presence of at least 1,000\u002FuL (i.e., a white blood cell \\[WBC\\] count \\>= 10,000\u002FuL with \\>= 10% blasts or a WBC count of \\>= 5,000\u002FuL with \\>= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment)\n* ARM C: Patient must be \\>= 2 years of age at the time of Late Callback\n* ARM C: Patient must have FLT3\u002FITD allelic ratio \\> 0.1 as reported by Molecular Oncology\n* ARM C: Patient does not have any congenital long QT syndrome or congenital heart block\n* ARM C: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib\n* ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib\n* ARM C: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib\n* ARM D: Patient must be \\>= 2 years of age at the time of Late Callback\n* ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating mutations as reported by Foundation Medicine\n* ARM D: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib\n* ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib\n* ARM D: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib\n* NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who transfer to Arm C or Arm D are not eligible\n* NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment\n* NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking\n* NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental retardation)\n* NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n\nExclusion Criteria:\n\n* Fanconi anemia\n* Shwachman Diamond syndrome\n* Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21\n* Telomere disorders\n* Germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy\n* Any concurrent malignancy\n* Juvenile myelomonocytic leukemia (JMML)\n* Philadelphia chromosome positive AML\n* Mixed phenotype acute leukemia\n* Acute promyelocytic leukemia\n* Acute myeloid leukemia arising from myelodysplasia\n* Therapy-related myeloid neoplasms\n* Patients with persistent cardiac dysfunction prior to enrollment, defined as ejection fraction (EF) \\\u003C 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) \\\u003C 24%. \\*Note: if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF \\>= 50%, the patient is eligible to enroll and may receive an anthracycline-containing Induction regimen\n* Administration of prior anti-cancer therapy except as outlined below:\n\n  * Hydroxyurea\n  * All-trans retinoic acid (ATRA)\n  * Corticosteroids (any route)\n  * Intrathecal therapy given at diagnosis\n  * In particular, strong inducers of CYP3A4 and\u002For P-glycoprotein (P-gp) should be avoided from the time of enrollment until it is determined whether the patient will receive gilteritinib. Patients receiving gilteritinib will be required to avoid strong CYP3A4 inducers and\u002For strong P-gp inducers for the duration of the study treatment\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation\n* ARM D: Patient does not have any congenital long QT syndrome or congenital heart block",{"count":101,"type":21},1186,[24],"This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and\u002For gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and\u002For bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and\u002For bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3\u002FITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and\u002For gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.",[105],"Acute Myeloid Leukemia","2026-07-28",{"date":62,"type":32},{"date":109,"type":32},"2020-07-21",{"date":111,"type":21},"2029-06-30",{"name":38,"class":39},205,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":17,"minAge":122,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100624620","quality-of-end-of-life-care-for-children-with-cancer-100624620","NCT07412002","Quality of End-of-Life Care for Children With Cancer","Quality of End-of-Life Care for Children With Cancer: A COG Groupwide Observational Study","Inclusion Criteria:\n\n* Index Child (COG Registered Patient):\n\n  * Must be deceased\n  * \\\u003C 18 years old at time of death\n  * Diagnosed with any oncologic condition\n  * History of enrollment on Stratum 1 of APEC14B1, Project:EveryChild\n\n    * Note: history of treatment on a COG therapeutic trial is not required\n  * Resided in the United States, including Puerto Rico, as evidenced by most recent address, at the time of death\n\nBereaved Parent(s):\n\n* Must be a parent, legal guardian, or caregiver (biological or non-biological) of an eligible Index Child enrolled on APEC14B1 with current Consent to Future Contact (e.g., from the APEC14B1 Part B Consent)\n* Self-reported confirmation of familiarity with the care received by the Index Child in the last month of their life\n* Bereaved parent must understand English or Spanish (written and\u002For spoken)\n* Must be a parent\u002Fguardian\u002Fkey contact from the Index Child's APEC14B1 Future Contact study record or must be referred by one of the APEC14B1 contacts\n* Bereaved parent must be \\>= 18 years old at the time of ALTE24C1 study enrollment\n\nRegulatory Requirements:\n\n* Bereaved parent must provide verbal or implied informed consent\n* For all participants, all institutional, FDA, and NCI requirements for human studies must be met",true,"18 Years",{"count":124,"type":21},2425,"This study examines the role of access to care, patient\u002Ffamily interactions with the healthcare system, and stress in explaining variations in quality of end of life care. The data collected from this study may help researchers develop a model for identifying patients at risk of low quality end of life care as well as recommendations for potential future interventions.",[127,128],"Childhood Hematopoietic and Lymphatic System Neoplasm","Childhood Malignant Solid Neoplasm","2026-07-15",{"date":131,"type":32},"2026-07-16",{"date":133,"type":32},"2026-06-15",{"date":135,"type":21},"2031-01-31",{"name":38,"class":39},15,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":17,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100594686","phase-3-xylitol-dental-wipes-for-the-reduction-of-bloodstream-infection-risk-in-children-with-acute-myeloid-leukemia-100594686","NCT07022678","Xylitol Dental Wipes for the Reduction of Bloodstream Infection Risk in Children With Acute Myeloid Leukemia","A Randomized Double-Blinded Trial of Xylitol Dental Wipes for the Prophylaxis of Bloodstream Infections From Oral Organisms in Pediatric Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Patient must be ≥ 1 year to ≤ 25 years old at enrollment.\n* Patient must have a diagnosis of AML according to the 2016 World Health Organization classification with or without extramedullary disease. Patients with either newly diagnosed or relapsed AML are eligible as long as they meet the planned treatment criteria.\n* Patient should be planned to receive at least 2 consecutive cycles of myelosuppressive chemotherapy. Each cycle must:\n\n  * Contain IV cytarabine (liposomal formulations allowed), and\n  * The duration of severe neutropenia should be expected to be ≥ 7 days. Hematopoietic stem cell transplantation (HSCT) conditioning cannot count as one of the two required planned cycles.\n\nNote: Patients do not need to be co-enrolled on an upfront AML treatment protocol study, but co-enrollment is permitted.\n\n* Minimum of one visible or erupted tooth.\n* Agree to avoid xylitol containing gum or toothpaste during intervention period.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients with Down syndrome-associated AML.\n* Prior therapy: Prior radiation treatment for cancer of oral cavity, head or neck in past 6 months per study participant's medical record.\n* Patients with known history of allergy to xylitol.\n* Patients with known history of allergy to grapes or grape flavoring.\n* Patients who are actively being treated for an oral organism related blood stream infection.\n* Patients for whom the practitioner believes are unable to comply with use of oral dental wipes.","1 Year","25 Years",{"count":148,"type":21},556,[24],"This phase III trial compares the effect of xylitol dental wipes to dental wipes without xylitol for the reduction of bloodstream infection in children with acute myeloid leukemia (AML). Xylitol is a naturally occurring sugar compound found in fruits and vegetables. Xylitol has been shown to limit the growth of bacteria in the mouth, and to reduce cavities, plaque on the teeth, and inflammation of the gums. Treatment for AML includes chemotherapy. Patients receiving chemotherapy for AML have a risk of developing bloodstream infections. Bloodstream infections can make patients very sick, can contribute to delays in treatment, and can even cause death. In AML patients, bacteria or fungus (yeast) can sometimes enter the bloodstream from the mouth. Using xylitol dental wipes may help to reduce bloodstream infections in children being treated for AML.",[105,152],"Recurrent Acute Myeloid Leukemia",{"date":131,"type":32},{"date":155,"type":32},"2026-05-26",{"date":157,"type":21},"2033-01-15",{"name":38,"class":39},28,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":167,"minAge":4,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":113},"100555582","phase-3-triptorelin-for-the-prevention-of-ovarian-damage-in-adolescents-and-young-adults-with-cancer-100555582","NCT06513962","Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer","Triptorelin and Protection of Ovarian Reserve in Adolescents and Young Adults With Cancer","Inclusion Criteria:\n\n* \\\u003C 40 years of age at the time of enrollment\n* Patient must be a post-menarchal female and report that their initial menstrual period occurred \\> 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)\n* Newly diagnosed with first cancer, exclusive of breast cancer.\n\n  * Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma).\n* Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard, or dacarbazine (DTIC).\n* Expected cumulative cyclophosphamide equivalent dose (CED):\n\n  * For patients \\\u003C 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g\u002Fm\\^2 cumulative CED calculated according to the equation and specified drugs listed. Dacarbazine is not an eligible drug in this age group.\n  * For patients ≥ 20 years of age and \\\u003C 35 years old at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed below that contribute to CED. Dacarbazine is not an eligible drug in this age group.\n  * For patients ≥ 35 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed that contribute to CED and\u002For dacarbazine, which IS an eligible drug in this age group.\n\nNote that CED includes all administration routes: intravenous (IV), oral (PO), IM.\n\n* The planned total duration of therapy with eligible alkylators is expected to be completed within one year after enrollment. Note: treatment plans with prolonged maintenance periods extending beyond one year are permitted so long as those maintenance treatments are not expected to contain eligible alkylators.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).\n* Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).\n* Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.\n* Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.\n* Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.\n* Receipt of systemic chemotherapy (except for steroids and intrathecal chemotherapy) more than 7 days prior to study enrollment.\n* Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).\n* Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.\n* Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).","FEMALE","39 Years",{"count":170,"type":21},60,[24],"This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with an alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.",[174,175],"Hematopoietic and Lymphatic System Neoplasm","Malignant Solid Neoplasm",{"date":177,"type":32},"2026-07-17",{"date":179,"type":32},"2025-02-27",{"date":181,"type":21},"2029-10-30",{"name":38,"class":39},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},"100544433","phase-2-a-study-of-lower-radiotherapy-dose-to-treat-children-with-cns-germinoma-100544433","NCT06368817","A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma","A Phase II Trial Evaluating Chemotherapy Followed by Response-Based Reduced Radiation Therapy for Patients With Central Nervous System Germinomas","Inclusion Criteria:\n\n* Patients must be ≥ 3 years and \\\u003C 30 years at the time of study enrollment\n* Patients must be newly-diagnosed primary localized germinoma of the suprasellar and\u002For pineal region by pathology and\u002For serum and\u002For CSF hCGbeta 5-50 mIU\u002FmL AND institutional normal AFP (or ≤ 10 ng\u002FmL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required\n* Patients with EITHER (A) bifocal (pineal + suprasellar) involvement OR (B) pineal lesion with diabetes insipidus (DI) AND hCGbeta ≤ 100 mIU\u002FmL in serum and\u002For CSF AND institutional normal AFP (or ≤ 10 ng\u002FmL if no institutional normal exists) in both serum and CSF. No histologic confirmation required\n* Patients with hCGbeta 51-100 mIU\u002FmL in serum and\u002For CSF and institutional normal AFP (or ≤ 10 ng\u002FmL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required\n* Patients with germinoma of the basal ganglia and or\u002Fthalamic primary sites are eligible\n* Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible\n* Patients with germinoma admixed with mature teratoma are eligible\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1-CNS\n* Imaging studies must be obtained within 31 days prior to study enrollment and start of protocol therapy. (Note: for patients that have had surgery and post-operative imaging performed, it is the post-operative MRI that must be obtained within 31 days prior to enrollment.)\n* Patients must have a cranial magnetic resonance imaging (MRI) with and without gadolinium at diagnosis\u002Fprior to enrollment. If surgical resection is performed, patients must have pre-operative and post-operative brain MRI with and without gadolinium. The post-operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required\n* Patients must have a spine MRI with gadolinium obtained at diagnosis\u002Fprior to enrollment\n* Patients must be enrolled, and protocol therapy must begin, no later than 31 days after definitive surgery or clinical diagnosis, whichever is later\n* Patients must have eligibility confirmed by Rapid Central Tumor Marker Review performed on APEC14B1-CNS\n* Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery. Of note, lumbar CSF should not be performed prior to obtaining spine MRI, as this can make interpretation of the spine MRI less clear\n* Patients must have CSF tumor markers obtained prior to study enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy\u002Fsurgery are combined, CSF tumor markers should be collected first. Ideally serum and CSF tumor markers should be collected at the same time and processed without delay\n* For patients with solid tumors: Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (Must be performed within 7 days prior to enrollment unless otherwise indicated)\n* For patients with solid tumors: Platelet count \\>= 100,000\u002FuL (transfusion independent) (Must be performed within 7 days prior to enrollment unless otherwise indicated)\n* For patients with solid tumors: Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell \\[RBC\\] transfusions) (Must be performed within 7 days prior to enrollment unless otherwise indicated)\n* For pediatric patients (age 3-17 years): A serum creatinine based on age\u002Fsex as follows (Must be performed within 7 days prior to enrollment unless otherwise indicated):\n\n  * Age: 3 to \\\u003C 6 years; maximum serum creatinine (mg\u002FdL): 0.8 (male); 0.8 (female)\n  * Age: 6 to \\\u003C 10 years; maximum serum creatinine (mg\u002FdL): 1 (male); 1 (female)\n  * Age: 10 to \\\u003C 13 years; maximum serum creatinine (mg\u002FdL): 1.2 (male); 1.2 (female)\n  * Age: 13 to \\\u003C 16 years; maximum serum creatinine (mg\u002FdL): 1.5 (male); 1.4 (female)\n  * Age: ≥ 17 years; maximum serum creatinine (mg\u002FdL): 1.7 (male); 1.4 (female) OR a 24-hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 OR a glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard).\n  * Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility.\n  * For adult patients (age 18 years or older) (Must be performed within 7 days prior to enrollment unless otherwise indicated):\n\n    * Creatinine clearance ≥ 70 mL\u002Fmin, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (Must be performed within 7 days prior to enrollment unless otherwise indicated)\n* Serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase \\[ALT\\]) ≤ 135 U\u002FL (Must be performed within 7 days prior to enrollment unless otherwise indicated)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination\n* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled\n* CNS toxicity =\\\u003C grade 2\n* Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load are eligible for this study\n\nExclusion Criteria:\n\n* Patients with any of the following malignant pathological elements are not eligible:\n\n  * Endodermal sinus (yolk sac)\n  * Embryonal carcinoma, choriocarcinoma\n  * Malignant\u002Fimmature teratoma and mixed germ cell tumor (GCT) (i.e., may include some germinoma)\n* Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible\n* Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n\n  * Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","3 Years","29 Years",{"count":193,"type":21},240,[53],"This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin \\& Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Researchers want to see if lowering the dose of standard radiotherapy (RT) after chemotherapy can help get rid of CNS germinomas with fewer long-term side effects.",[197,198,199,200,201,202],"Basal Ganglia Germinoma","Diabetes Insipidus","Germinoma","Pineal Region Germinoma","Suprasellar Germinoma","Thalamic Germinoma",{"date":131,"type":32},{"date":205,"type":32},"2024-10-22",{"date":207,"type":21},"2033-11-04",{"name":38,"class":39},114,{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":217,"maxAge":49,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100468634","phase-3-a-study-of-treatment-for-medulloblastoma-using-sodium-thiosulfate-to-reduce-hearing-loss-100468634","NCT05382338","A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss","A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children With Average-Risk Medulloblastoma and Reduced Therapy in Children With Medulloblastoma With Low-Risk Features","Inclusion Criteria:\n\n* PRE-ENROLLMENT: Patients must be ≥ 4 years and ≤ 21 years of age at the time of enrollment\n* PRE-ENROLLMENT: Patient is suspected to have newly-diagnosed medulloblastoma by institutional diagnosis\n\n  * Please note: Patients with a pending result of CSF cytology tests are eligible for NCI-2014-02057 (APEC14B1-Central Nervous System \\[CNS\\]) and CNS\u002FMedulloblastoma Pre Enrollment Eligibility Screening\n* PRE-ENROLLMENT: The patient and\u002For their parents or legal guardians must have signed informed consent for APEC14B1 Part A - Eligibility Screening and consent for the Molecular Characterization Initiative (MCI)\n* PRE-ENROLLMENT: The required specimens are projected to be submitted under APEC14B1-CNS as soon as possible, preferably within 5 days of definitive surgery\n* PRE-ENROLLMENT: All patients must have rapid central pathology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1 in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031.\n\n  * Note: Patients with a pending result of CSF cytology tests are eligible for the rapid central pathology screening review. Confirmation of CSF negativity is needed for enrollment on the ACNS2031 protocol\n* PRE-ENROLLMENT: All patients must have rapid central molecular screening review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1, in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031\n* PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central imaging screening review under APEC14B1 prior to study enrollment on ACNS2031 step 1\n\n  * Note: Patients must not have metastatic disease on cranial or spinal MRI. Patients with \\> 1.5 cm\\^2 residual tumor after initial surgical resection may undergo a second surgical resection prior to subsequent therapy to render them eligible for this study. The day of the second resection to remove residual tumor will be regarded as the day of definitive surgery (Day 0) and must be within a month (31 days) of the initial resection\n* PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central audiology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1\n* Patients must be \\>= 4 years and =\\\u003C 21 years of age at the time of enrollment\n* Patients must be newly diagnosed and have eligibility confirmed by rapid central pathology and molecular screening reviews performed on APEC14B1 and via the Molecular Characterization Initiative\n* Average-risk cohort\n\n  * Clinico-pathologic criteria:\n\n    * M0 disease\n    * No diffuse anaplastic histology AND\n  * Molecular criteria:\n\n    * SHH, p53wt, GLI2 normal, MYCN normal, no chromosome 14q loss\n    * Group 3, MYC normal, no isochromosome 17q\n    * Group 4, no chromosome 11 loss\n* Low-risk features cohort\n\n  * Clinico-pathologic criteria:\n\n    * M0 disease\n    * No diffuse anaplastic histology AND\n  * Molecular criteria:\n\n    * Group 4, chromosome 11 loss\n* Patients must have negative lumbar CSF cytology\n\n  * Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF. Ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study. Patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status. Patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated. Patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively\n* Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1. Patients must have =\\\u003C 1.5 cm\\^2 cross-sectional area of residual tumor. Whole brain MRI with and without gadolinium and spine MRI with gadolinium must be performed\n* Patients must weigh \\> 10 kg\n* Patients must be enrolled, and protocol therapy must be projected to begin, no later than 31 days after definitive diagnostic surgery (day 0)\n* Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (within 7 days prior to enrollment)\n* Platelet count \\>= 100,000\u002FuL (transfusion independent) (within 7 days prior to enrollment)\n* Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell count \\[RBC\\] transfusions) (within 7 days prior to enrollment)\n* A serum creatinine (within 7 days prior to enrollment) based on age\u002Fsex as follows:\n\n  * 4 to \\\u003C 6 years (age); 0.8 mg\u002FdL (male) 0.8 mg\u002FdL (female)\n  * 6 to \\\u003C 10 years (age); 1 mg\u002FdL (male) 1 mg\u002FdL (female)\n  * 10 to \\\u003C 13 years (age); 1.2 mg\u002FdL (male) 1.2 mg\u002FdL (female)\n  * 13 to \\\u003C 16 years (age); 1.5 mg\u002FdL (male) 1.4 mg\u002FdL (female)\n  * \\>= 16 years (age); 1.7 mg\u002FdL (male) 1.4 mg\u002FdL (female) OR a 24 hour urine Creatinine clearance \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 (within 7 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n  * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)\n* Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL (within 7 days prior to enrollment)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* Central nervous system function defined as:\n\n  * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled\n  * Patients must not be in status epilepticus, a coma or assisted ventilation at the time of study enrollment\n* Auditory function defined as:\n\n  * Patients must have normal hearing (defined as International Society of Pediatric Oncology \\[SIOP\\] grade 0) in at least one ear confirmed by rapid central audiology review performed on APEC14B1 prior to enrollment\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n\nExclusion Criteria:\n\n* Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible. Patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible\n* Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and\u002For corticosteroids\n* Patients must not have any known hypersensitivity to STS, sulfates\u002Fsulfites, or other thiol agents (e.g., amifostine, n-acetylcysteine, MESNA, and captopril)\n* Pregnancy and Breastfeeding:\n\n  * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n  * Lactating females who plan to breastfeed their infants\n  * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation","4 Years",{"count":219,"type":21},225,[24],"This phase III trial tests two hypotheses in patients with low-risk and average-risk medulloblastoma. Medulloblastoma is a type of cancer that occurs in the back of the brain. The term, risk, refers to the chance of the cancer coming back after treatment. Subjects with low-risk medulloblastoma typically have a lower chance of the cancer coming back than subjects with average-risk medulloblastoma. Although treatment for newly diagnosed average-risk and low-risk medulloblastoma is generally effective at treating the cancer, there are still concerns about the side effects of such treatment. Side effects or unintended health conditions that arise due to treatment include learning difficulties, hearing loss or other issues in performing daily activities. Standard therapy for newly diagnosed average-risk or low-risk medulloblastoma includes surgery, radiation therapy, and chemotherapy (including cisplatin). Cisplatin may cause hearing loss as a side effect. In the average-risk medulloblastoma patients, this trial tests whether the addition of sodium thiosulfate (STS) to standard of care chemotherapy and radiation therapy reduces hearing loss. Previous studies with STS have shown that it may help reduce or prevent hearing loss caused by cisplatin. In the low-risk medulloblastoma patients, the study tests whether a less intense therapy (reduced radiation) can provide the same benefits as the more intense therapy. The less intense therapy may cause fewer side effects. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. The overall goals of this study are to see if giving STS along with standard treatment (radiation therapy and chemotherapy) will reduce hearing loss in medulloblastoma patients and to compare the overall outcome of patients with medulloblastoma treated with STS to patients treated without STS on a previous study in order to make sure that survival and recurrence of tumor is not worsened.",[223],"Childhood Medulloblastoma",{"date":131,"type":32},{"date":226,"type":32},"2023-02-20",{"date":228,"type":21},"2029-12-31",{"name":38,"class":39},108,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":146,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},"100359362","phase-3-inotuzumab-ozogamicin-and-post-induction-chemotherapy-in-treating-patients-with-high-risk-b-all-mixed-phenotype-acute-leukemia-and-b-lly-100359362","NCT03959085","Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy","A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy","Inclusion Criteria:\n\n* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.\n* APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.\n* Patients must be \\> 365 days and \\\u003C 25 years of age\n* Initial white blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-9.99 years: WBC \\>= 50,000\u002FuL\n  * Age 10-24.99 years: Any WBC\n  * Age 1-9.99 years: WBC \\\u003C 50,000\u002FuL with one or more of the following:\n\n    * Testicular leukemia\n    * CNS leukemia (CNS3)\n    * Steroid pretreatment.\n* Initial white blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction.\n* Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \\[WHO\\] 2016 criteria) with \\>= 25% blasts on a bone marrow (BM) aspirate;\n\n  * OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;\n  * OR A complete blood count (CBC) documenting the presence of at least 1,000\u002FuL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.\n* Patient has newly diagnosed B-LLy Murphy stages III or IV.\n* Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.\n* Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.\n* Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. Note that once cerebrospinal fluid (CSF) has been collected, protocol therapy can be initiated while final determination of CNS status is pending. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.\n* Direct bilirubin \\\u003C 2.0 mg\u002FdL (34 micromoles\u002FL)\n* Alanine aminotransferase (ALT) ≤ 10x upper limit of normal (ULN). For the purposes of this study, the ULN for ALT is defined as 45 U\u002FL\n* Exceptions to this include patients with known Gilbert's Syndrome, or those with hepatic involvement from leukemic or lymphomatous infiltration\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients with Down syndrome are not eligible\n* With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.\n* Patients who have received \\> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.\n* Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \\> 1,000\u002FuL circulating leukemia cells.\n* Patients with acute undifferentiated leukemia (AUL) are not eligible.\n* For Murphy stage III\u002FIV B-LLy patients, or stage I\u002FII patients with steroid pretreatment, the following additional exclusion criteria apply:\n\n  * T-lymphoblastic lymphoma.\n  * Morphologically unclassifiable lymphoma.\n  * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.\n* Patients with known Charcot-Marie-Tooth disease.\n* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.\n* Patients requiring radiation at diagnosis.\n* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.",{"count":239,"type":21},5951,[24],"This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab.\n\nThe overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.",[243,244,245,246,247],"B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Central Nervous System Leukemia","Mixed Phenotype Acute Leukemia","Testicular Leukemia",{"date":131,"type":32},{"date":250,"type":32},"2019-10-31",{"date":252,"type":21},"2032-03-31",{"name":38,"class":39},231,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":303},"100290931","phase-3-active-surveillance-bleomycin-etoposide-carboplatin-or-cisplatin-in-treating-pediatric-and-adult-patients-with-germ-cell-tumors-100290931","NCT03067181","Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors","A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors","Inclusion Criteria:\n\n* There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \\[all sites\\])\n* Standard risk 1: Patients must be \\\u003C 11 years of age at enrollment\n* Standard risk 2: Patients must be \\>= 11 and \\\u003C 25 years of age at enrollment\n* Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher).\n\n  * Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions:\n\n    * Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to \\> 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided\n    * Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein \\[AFP- ≥ 500 ng\u002FmL or HCG ≥ 500 IU\u002FL) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently\n* Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor \\[\\\u003C 3 mm\\], but no other pathological evidence of MGCT); tumor markers: alpha-FP =\\\u003C 1,000 ng\u002FmL, beta-HCG institutional normal; all ages\n* Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages\n* Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature\u002Fmature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages\n* Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification \\[IGCCC\\] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \\\u003C 11\n* Standard risk 2 (SR2)\n\n  * Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \\>= 11 and \\\u003C 25\n  * Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk; post op: alpha-FP \\\u003C 1,000 ng\u002FmL, beta-HCG \\\u003C 5,000 IU\u002FmL and lactate dehydrogenase (LDH) \\\u003C 3.0 x normal; age (years) \\>= 11 and \\\u003C 25\n* Notes:\n\n  * IGCCC criteria only apply to SR2 patients with a testicular primary tumor\n  * Use post-op tumor marker levels to determine IGCCC risk group\n  * Pure seminoma patients are not eligible for the standard risk arms of the study\n  * For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a \"microscopic component\" of yolk sac tumor\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)\n* Adequate renal function defined as:\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 (within 7 days prior to enrollment) OR\n* A serum creatinine based on age\u002Fsex as follows (within 7 days prior to enrollment): (mg\u002FdL)\n\n  * 1 month to \\\u003C 6 months male: 0.4 female: 0.4\n  * 6 months to \\\u003C 1 year male: 0.5 female: 0.5\n  * 1 to \\\u003C 2 years male: 0.6 female: 0.6\n  * 2 to \\\u003C 6 years male: 0.8 female: 0.8\n  * 6 to \\\u003C 10 years male: 1 female: 1\n  * 10 to \\\u003C 13 years male: 1.2 female: 1.2\n  * 13 to \\\u003C 16 years: male: 1.5 female: 1.4\n  * \\>= 16 years male: 1.7 female: 1.4\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x upper limit of normal (ULN) (within 7 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (within 7 days prior to enrollment) AND\n* Platelet count \\>= 75,000\u002Fmm\\^3 (within 7 days prior to enrollment)\n* Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment\n* Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes \\[PROs\\] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate\n* \\>= 11 and \\\u003C 25 years old at enrollment\n* Able to fluently speak and read English\n* Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor\n* Followed for cancer or survivorship care at one of the following institutions:\n\n  * Baylor College of Medicine\u002FDan L Duncan Comprehensive Cancer Center\n  * Dana Farber\u002FHarvard Cancer Center\n  * Hospital for Sick Children\n  * Children's Hospital of Eastern Ontario\n  * Oregon Health and Science University\n  * Seattle Children's Hospital\n  * Yale University\n\nExclusion Criteria:\n\n* Patients with any diagnoses not listed including:\n\n  * Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)\n  * Pure ovarian or extragonadal dysgerminoma\u002Fseminoma\n  * Pure mature teratoma\n  * Pure immature teratoma with alpha-fetoprotein (AFP) \\>= 1000 ng\u002FmL\n  * \"Poor risk\" GCT (age \\>= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or\n  * Primary central nervous system (CNS) germ cell tumor\n  * Germ cell tumor with somatic malignant transformation\n  * Spermatocytic seminoma\n* Patients must have had no prior systemic therapy for the current cancer diagnosis\n* Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain \\[stage IV disease\\] would be considered poor risk and therefore not eligible for this trial)\n* Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])\n* Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy \\[SR1 and SR2 patients\\])",{"count":263,"type":21},1780,[24],"This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.",[267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296],"Childhood Extracranial Germ Cell Tumor","Extragonadal Embryonal Carcinoma","Germ Cell Tumor","Malignant Germ Cell Tumor","Malignant Ovarian Teratoma","Stage I Ovarian Choriocarcinoma","Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage I Testicular Choriocarcinoma AJCC v6 and v7","Stage I Testicular Embryonal Carcinoma AJCC v6 and v7","Stage I Testicular Seminoma AJCC v6 and v7","Stage I Testicular Yolk Sac Tumor AJCC v6 and v7","Stage II Ovarian Choriocarcinoma","Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage II Testicular Choriocarcinoma AJCC v6 and v7","Stage II Testicular Embryonal Carcinoma AJCC v6 and v7","Stage II Testicular Yolk Sac Tumor AJCC v6 and v7","Stage III Ovarian Choriocarcinoma","Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7","Stage III Testicular Choriocarcinoma AJCC v6 and v7","Stage III Testicular Embryonal Carcinoma AJCC v6 and v7","Stage III Testicular Yolk Sac Tumor AJCC v6 and v7","Stage IV Ovarian Choriocarcinoma","Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7","Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7","Testicular Mixed Choriocarcinoma and Embryonal Carcinoma","Testicular Mixed Choriocarcinoma and Teratoma","Testicular Mixed Choriocarcinoma and Yolk Sac Tumor",{"date":131,"type":32},{"date":299,"type":32},"2017-05-25",{"date":301,"type":21},"2027-06-30",{"name":38,"class":39},629,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":4},"100582068","phase-2-comparing-123i-mibg-and-18f-mfbg-imaging-in-patients-with-newly-diagnosed-high-risk-neuroblastoma-100582068","NCT06858501","Comparing 123I-MIBG and 18F-MFBG Imaging in Patients With Newly Diagnosed, High Risk Neuroblastoma","Concordance in Response Assessment Incorporating Meta-Iodobenzylguanidine (123I-MIBG) and Meta-[18F]Fluorobenzylguanidine (18F-MFBG, IND#146379, NSC#853868) Imaging in Neuroblastoma","Inclusion Criteria:\n\n* Any age at diagnosis.\n* Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular, unfavorable subtype) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.\n* Patients must have high-risk neuroblastoma defined as one of the following:\n\n  * Any age with International Neuroblastoma Risk Group (INRG) stage L2 or M and MYCN amplification.\n  * Age ≥ 547 days and INRG stage M regardless of biologic features.\n  * Age ≥ 547 days and INRG stage L2 with unfavorable histology.\n* Patients must have newly diagnosed disease.\n* Patients must have either measurable or evaluable disease by INRC.\n* Patients observed or treated with a single cycle of chemotherapy per a low- or intermediate-risk neuroblastoma regimen (e.g. as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease, but subsequently found to meet high-risk criteria will be eligible. These patients must enroll prior to the start of high-risk therapy.\n* Patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible.\n* Patients initially recognized to have high-risk disease must enroll prior to or within the first week after starting high-risk induction chemotherapy.\n* Induction therapy as per a standard high-risk neuroblastoma induction regimen (examples include ANBL1531 arm A, ANBL2131 arm A, or ANBL2131 arm B) must be planned for patients to be eligible for this study.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events of radiation. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) at least 48 hours prior to and following all imaging studies. Abstinence is an acceptable method of birth control.\n* Norepinephrine transporter (NET)-dependent agents: Many medications are known to interfere with uptake of NET-dependent agents. Investigators should use caution when prescribing these medications for patients undergoing procedures on this study. Medications that are known to substantially interfere with uptake of NET-dependent agents should be held if possible, based on patient condition 24 hours prior to each 18F-MFBG scan. These agents can be resumed immediately after each 18F-MFBG scan is completed. Patients who are receiving medications that are known to significantly interfere with uptake of NET-dependent agents (primarily tricyclic antidepressants, psychostimulants, and antihypertensives) and for whom these medications cannot be safely withheld before the start of study procedures will not be eligible.\n* The patient has a known or suspected history of significant allergic reaction or anaphylaxis to any components of the 18F-MFBG or 123I-MIBG imaging agents.\n* Patients who will require sedation or anesthesia only for 18F-MFBG imaging.\n\n  * Note: Patients who need anesthesia will be required to have 18F-MFBG imaging combined with other scans or procedures necessary for clinical care (ex: MRI, bone marrow aspirate\u002Fbiopsies, line placement).\n* Patients will be able to enroll prior to baseline 123I-MIBG imaging. However, patients who have had their baseline standard of care 123I-MIBG imaging prior to enrollment who have known MIBG non-avid disease are not eligible.\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.",{"count":312,"type":21},84,[53],"This phase II trial evaluates whether an investigational scan (18F-MFBG positron emission tomography \\[PET\\]\u002Fcomputed tomography \\[CT\\] or PET\u002Fmagnetic resonance imaging \\[MRI\\]) can accurately detect tumors in patients with newly diagnosed, high-risk neuroblastoma as well as standard of care imaging with 123 I-MIBG. 18F-MFBG is a radioactive diagnostic agent that is injected into a vein and taken up by tumor cells. The cells can then be visualized using PET\u002FCT or PET\u002FMRI scans. A PET scan uses radioactive material injected into the blood to show the internal workings of the body. A CT scan uses x-rays and a computer to produce a 3-dimensional image of the body. MRI uses radiofrequency waves and a strong magnetic field rather than x-rays to provide clear and detailed pictures of internal organs and tissues. Combining PET with CT or MRI may help doctors better understand the extent and the exact location of disease. Diagnostic procedures, such as 18F-MFBG PET\u002FCT or PET\u002FMRI, may detect tumors as well as or better than the current standard imaging with 123 I-MIBG in patients with newly diagnosed, high-risk neuroblastoma.",[316,317,318],"Ganglioneuroblastoma","Ganglioneuroblastoma, Nodular","High Risk Neuroblastoma","2026-06-25",{"date":321,"type":32},"2026-06-29",{"date":323,"type":21},"2026-09-22",{"date":325,"type":21},"2028-12-20",{"name":38,"class":39},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":146,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":4},"100637599","a-study-on-how-to-safely-guide-surgery-for-melanoma-and-similar-skin-tumors-in-children-using-pathology-and-genetic-information-100637599","NCT07621614","A Study on How to Safely Guide Surgery for Melanoma and Similar Skin Tumors in Children Using Pathology and Genetic Information","A Multi-Institutional Central Pathology and Molecular Risk-Based Stratification Study of Surgical Management for Melanoma, Atypical Spitz\u002FSpitzoid Tumors, and Other Atypical Melanocytic Neoplasms in Pediatric Patients","Inclusion Criteria:\n\n* Patients ≤ 25 years old\n* Newly diagnosed localized cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors, or other atypical melanocytic neoplasm by local institution pathology report\n* Patients must have disease that is localized to the skin on clinical assessment. Note that staging imaging is not required for the determination of eligibility, but if obtained prior to enrollment, all imaging must be consistent with localized cutaneous disease\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* Patients must not have received any prior chemotherapy, immunotherapy, targeted therapy, radiation, or surgical therapy for melanoma other than the permitted biopsy\u002Fexcision of the lesion for which they are enrolling. Note that prior biopsies\u002Fsurgery for other benign melanocytic lesions is permitted\n\nExclusion Criteria:\n\n* Patients ≥ 18 years old with conventional adult-type melanoma are excluded. Note that patients 18-25 years old with atypical Spitz\u002FSpitzoid tumors, or other atypical melanocytic neoplasms are eligible\n* Patients with clinical evidence of metastatic disease such as palpable malignant adenopathy or symptomatic distant metastases are not eligible\n* Patients who have undergone re-excision to achieve a negative margin or sentinel lymph node biopsy for the melanocytic neoplasm under study are not eligible. Note that this does not exclude patients who have undergone the permitted diagnostic biopsy\u002Fexcision, including re-biopsy, of the lesion\n* Any of the following diagnoses\n\n  * Congenital nevi-associated proliferative nodules\n  * Agminated Spitz nevi\u002Ftumors\n  * Dysplastic nevus\n  * Combined nevus\n  * CRTC1::TRIM11 and\u002For MED15::ATF1 fused tumors (molecular testing is not required prior to enrollment)\n* Pre-existing conditions:\n\n  * Solid organ transplant recipients\n  * Known melanoma predisposition syndrome (i.e., patients with previously known pathogenic variants in moderate and high penetrance melanoma susceptibility genes \\[i.e., CDKN2A, CDK4, BAP1, POT1, TERT promoter, ACD, TERF2IP\\] or Xeroderma Pigmentosum). Note germline testing is not required prior to enrollment\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met",{"count":335,"type":21},51,[337],"NA","This clinical trial compares the effect of using risk-based stratification to guide surgical management to the usual approach in treating cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors or other atypical melanocytic tumors that have not spread to other parts of the body (localized). Melanoma is a cancer that in children is sometimes difficult to tell apart from benign (not harmful) or atypical (uncertain if harmful) skin lesions. Failure to diagnose melanoma can result in inadequate surgical removal and increase the risk of recurrence and metastatic disease (spread from where it first started to other places in the body). In addition, diagnosing a tumor a benign (not cancer) tumor as cancer may lead to unnecessary surgery and treatment. This trial reviews tumor pathology and genetic markers and classifies the tumor as not atypical, atypical but low risk for spread and\u002For recurrence (coming back after a period of improvement), and atypical and high risk for spread and\u002For recurrence. The classifications are then used to provide surgical recommendations. Tumors that are not atypical do not receive any surgical treatment. Low-risk recommendations include removing a small layer of normal skin around the tumor. High-risk recommendations include the usual adult melanoma approach of removing a larger layer of normal skin around the tumor with or without a biopsy of the sentinel lymph node (the first lymph node to which tumor cells are likely to spread from a primary tumor). Risk-based guided surgical management may help avoid unnecessary surgery while improving outcomes in younger patients with localized cutaneous melanoma, atypical Spitz\u002FSpitzoid tumors or other atypical melanocytic tumors.",[340,341,342,343,344,345],"Clinical Stage 0 Cutaneous Melanoma AJCC v8","Clinical Stage I Cutaneous Melanoma AJCC v8","Clinical Stage II Cutaneous Melanoma AJCC v8","Cutaneous Melanocytic Neoplasm","Cutaneous Melanoma","Cutaneous Spitz Melanocytoma","2026-06-03",{"date":348,"type":32},"2026-06-05",{"date":350,"type":21},"2026-08-18",{"date":352,"type":21},"2028-07-31",{"name":38,"class":39},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":380},"100193148","effects-of-dexrazoxane-hydrochloride-on-biomarkers-associated-with-cardiomyopathy-and-heart-failure-after-cancer-treatment-100193148","NCT01790152","Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment","Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy","Inclusion Criteria:\n\nStudy Strata I, II, and III are closed for further patient entry as of March 31, 2021. The study remains open for existing medical record submission of Stratum IV\n\n* STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS\n* Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)\n* STRATUM I: Alive and in continuous first complete remission from their original cancer (leukemia\u002Flymphoblastic lymphoma \\[P9404, high-risk DFCI 95-01\\] or Hodgkin lymphoma \\[P9425\u002FP9426\\])\n* STRATUM I: Did not have progressive disease or induction failure requiring off-protocol therapy including hematopoietic cell transplantation\n* STRATUM I: Must not have been diagnosed with any subsequent malignancy that required additional cardiotoxic therapies (i.e., radiotherapy to the chest \\[also includes fields directed towards the neck, upper abdomen, or spine\\], or additional anthracyclines or anthraquinones); patients with history of subsequent malignancy that did not require such therapies remain eligible\n* STRATUM I: All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM II: Among leukemia and lymphoma patients randomized to + or - DRZ on P9404, P9425, P9426, and DFCI 95-01 (high risk patients only) who have relapsed or have experienced a subsequent malignancy that precludes eligibility since their original diagnosis, the study committee will review the available data (both from Children's Oncology Group's \\[COG?s\\] Statistics and Data Center \\[SDC\\] and the participating institution) to determine if individual patients are to be selected for Stratum 2; in recognition that local institutions sometimes have more updated relapse\u002Fsubsequent cancer data than SDC, in cases where local data is more updated, local data will be used preferentially; the study will petition the Institutional Review Board (IRB) specifically for a waiver of consent to include any relapse and subsequent cancer data obtained from existing records for analysis of the secondary aims; patients selected for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but who lack clear confirmation in existing records (either at SDC or at the local institution)\n* STRATUM II: Alive, but have experienced relapse of their original cancer and\u002For have developed a subsequent cancer (other than non-melanomatous skin cancer) since their original diagnosis\n* STRATUM II: All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM III: OSTEOSARCOMA SURVIVORS\n* Previously enrolled osteosarcoma survivors treated on P9754 who are alive and able (themselves and\u002For parents\u002Flegal guardian) to provide written informed consent; note that relapse and subsequent malignancy are not exclusion criteria for P9754 survivors\n* Comparison subjects for P9754 survivors will be eligible to be enrolled from any ALTE11C2 participating COG site (even if that institution did not participate on P9754), according to the following criteria:\n\n  * Newly diagnosed, previously untreated biopsy-proven moderate or high grade osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal or periosteal sarcoma are ineligible\n  * \\\u003C 31 years of age at time of initial osteosarcoma diagnosis\n  * Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of therapy can extend beyond 2002\n  * No evidence of poor or low cardiac function at time of initial osteosarcoma diagnosis; if reports from the time are available: shortening fraction \\>= 28% by echocardiogram and within the institutional normative range for age, or radionuclide angiogram ejection fraction \\>= 50%; if imaging reports from the time are no longer available, there must be no documentation within available medical records that suggest poor or low cardiac function at time of diagnosis\n  * Comparison subject must have institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) documenting lifetime receipt of 450 to 600 mg\u002Fm\\^2 of doxorubicin (doses within 10% are acceptable); this includes initial therapy as well as any subsequent therapy for relapse or second cancer, if relevant; as such, comparison subjects who have had osteosarcoma relapse or subsequent malignancies remain eligible so long as they meet all other eligibility criteria\n  * No anthracycline or anthraquinone aside from doxorubicin was ever given as part of initial or subsequent therapies\n  * No exposure to DRZ at any point in time\n  * All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM IV: CARDIOMYOPATHY CASES, NOT OTHERWISE ELIGIBLE FOR STRATUMS 1, 2, AND 3\n* Individuals diagnosed with cancer prior to age 21 years, who required treatment with chemotherapy and\u002For radiotherapy, achieved initial remission, and remained alive after completing anti-cancer-therapy for at least 1 year\n* Must have screening echocardiograms for heart function as part of cancer therapy and off-therapy evaluations available (Digital Imaging and Communications in Medicine \\[DICOM\\] format). Images from Video Home System (VHS) tapes and reports only (without images) are not suitable\n* Cannot have a known history of congenital heart disease (patent foramen ovale remain eligible) or underlying genetic syndrome associated with abnormal cardiovascular development or health (e.g., down syndrome)\n* Based on echocardiography, must have either left ventricular fractional shortening =\\\u003C 28.0% or ejection fraction =\\\u003C 50.0% on at least two occasions, with at least one of these measurements occurring after cancer therapy completion and be in the absence of sepsis or any uncontrolled infection\n* If the fractional shortening or ejection fraction criteria is only met on one occasion, this must be after cancer therapy completion, be in the absence of sepsis or any uncontrolled infection, and the patient must have subsequently started on chronic medical therapy for cardiomyopathy (e.g., beta-blocker, angiotensin-converting enzyme \\[ACE\\]-inhibitor, angiotensin receptor blocker) lasting at least 6 months\n* For all participants (stratums 1, 2, 3, and 4), all institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met",{"count":362,"type":21},420,"This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.",[365,366,367,368,369,370,371],"Hodgkin Lymphoma in Remission","Leukemia in Remission","Lymphoblastic Lymphoma","Osteosarcoma","Recurrent Leukemia","Recurrent Lymphoma","Recurrent Malignant Neoplasm","2026-05-14",{"date":374,"type":32},"2026-05-18",{"date":376,"type":32},"2014-03-05",{"date":378,"type":21},"2026-12-31",{"name":38,"class":39},79,{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":49,"enrollmentInfo":388,"targetDuration":4,"studyType":22,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":402},"100565882","phase-3-testing-a-standardized-approach-to-surgery-and-chemotherapy-for-type-i-pleuropulmonary-blastoma-or-the-addition-of-an-anti-cancer-drug-topotecan-to-the-usual-treatment-for-types-ii-and-iii-pleuropulmonary-blastoma-100565882","NCT06647953","Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma","Prospective Treatment of Types I, II and III Pleuropulmonary Blastoma (PPB)","Inclusion Criteria:\n\n* 21 years of age or younger\n* Newly diagnosed PPB. Note that patients with known germline DICER1 variant or mosaicism with a large, solid unresectable thoracic mass with imaging features characteristic for Type II or III PPB are eligible without histologic confirmation of the diagnosis if a biopsy of the mass is not considered safe or feasible\n\n  * Individuals are eligible based on institutional diagnosis of Type I, Ir, II or III PPB diagnosed within 60 days prior to enrollment. Children with Type II or III PPB at risk for clinical decompensation may receive protocol therapy while awaiting rapid central pathology review. Children with Type I or Ir PPB will be assigned to chemotherapy vs. observation based on imaging and central pathology review diagnosis. Type I and Ir patients should not begin chemotherapy prior to return of central pathology results\n* For patients with Type II or III PPB (within 7 days prior to enrollment): A serum creatinine based on age\u002Fsex as follows:\n\n  * Age: 1 month to \\\u003C 6 months - Maximum Serum Creatinine (mg\u002FdL): 0.4 (Male), 0.4 (Female)\n  * Age: 6 months to \\\u003C 1 year - Maximum Serum Creatinine (mg\u002FdL): 0.5 (Male), 0.5 (Female)\n  * Age: 1 to \\\u003C 2 years - Maximum Serum Creatinine (mg\u002FdL): 0.6 (Male), 0.6 (Female)\n  * Age: 2 to \\\u003C 6 years - Maximum Serum Creatinine (mg\u002FdL): 0.8 (Male), 0.8 (Female)\n  * Age: 6 to \\\u003C 10 years - Maximum Serum Creatinine (mg\u002FdL): 1 (Male), 1 (Female)\n  * Age: 10 to \\\u003C 13 years - Maximum Serum Creatinine (mg\u002FdL): 1.2 (Male), 1.2 (Female)\n  * Age: 13 to \\\u003C 16 years - Maximum Serum Creatinine (mg\u002FdL): 1.5 (Male), 1.4 (Female)\n  * Age: ≥ 16 years - Maximum Serum Creatinine (mg\u002FdL): 1.7 (Male), 1.4 (Female) OR - A 24 hour urine creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 OR - A glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n  * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* For patients with Type II or III PPB (within 7 days prior to enrollment): Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age\n* For patients with Type II or III PPB (within 7 days prior to enrollment): Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) ≤ 135 U\u002FL\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram (within 21 days prior to start of protocol therapy)\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of CYP3A4\n\nExclusion Criteria:\n\n* Administration of prior PPB-directed chemotherapy is an exclusion criterion. Prior treatment for another malignancy is not an exclusion criterion\n* Patients with known Charcot-Marie-Tooth disease\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met",{"count":389,"type":21},110,[24],"This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB.\n\nHistorically, most children with type I PPB had surgery and approximately 40% of children with type I PPB received chemotherapy following their surgery, usually for 22-42 weeks. There has not been a consistent standard for which children with type I PPB receive chemotherapy after surgery. For patients whose tumor has been removed completely with surgery, observation without chemotherapy may work as well as giving chemotherapy after surgery in preventing a return of the PPB tumor.\n\nThe standard chemotherapy for patients with types II or III PPB in the United States is four cycles of IVADo (ifosfamide, vincristine, dactinomycin, and doxorubicin) followed by 8 cycles of IVA (ifosfamide, vincristine and dactinomycin). Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by interfering with tumor cell DNA which kills them. Giving topotecan in addition to standard IVADo and IVA chemotherapy regimens may shrink the cancer as well as or better than the standard therapy or could decrease the chance the tumor spreads while causing fewer side effects.",[393],"Pleuropulmonary Blastoma","2026-05-01",{"date":396,"type":32},"2026-05-05",{"date":398,"type":32},"2025-03-21",{"date":400,"type":21},"2029-03-31",{"name":38,"class":39},82,{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":17,"minAge":145,"maxAge":168,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":412,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100563756","phase-1-testing-the-addition-of-an-anti-cancer-drug-dt2216-to-the-usual-chemotherapy-treatment-for-relapsed-or-refractory-solid-tumors-and-fibrolamellar-carcinoma-100563756","NCT06620302","Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar Carcinoma","DT2216 in Combination With Irinotecan for Children, Adolescents and Young Adults With Relapsed or Refractory Solid Tumors: A Phase I Study With Phase II Feasibility Cohort for Fibrolamellar Carcinoma","Inclusion Criteria:\n\n* PHASE 1: Patients between ≥ 1 year and ≤ 21 years of age at the time of study enrollment\n* PHASE 2: Patients between ≥ 1 year and ≤ 39 years of age at the time of study enrollment\n* PHASE 1: Patients with recurrent\u002Frefractory solid tumors excluding primary central nervous system tumors\n* PHASE 2: Patients with (FLC), which must include genomic confirmation of the DNAJB1:PRKACA fusion performed at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory\n* PHASE 1: Patients must have either measurable or evaluable disease\n* PHASE 2: Patients must have measurable disease\n* PHASE 1: Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life\n* PHASE 2: Patients must have FLC which is recurrent\u002Frefractory to at least one line of prior systemic therapy\n* Patients with FLC that is unresectable at initial diagnosis but is not recurrent\u002Frefractory to at least one prior line of systemic therapy nor metastatic are NOT eligible for either phase 1 or phase 2\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age\n* Patients must have fully recovered (grade \\\u003C 2) from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, eg, blood count criteria, the patient is considered to have recovered adequately\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: See Developmental Therapeutics (DVL) homepage on the Children's Oncology Group (COG) members site for commercial and investigational agent classifications. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\n\n    * Solid tumor patients: ≥ 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea). Please refer to the table of myelosuppressive\u002Fanticancer agents on the COG website\n  * Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): ≥ 7 days after the last dose of agent. See the DVL homepage on the COG Members site for commercial and investigational agent classifications. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\n  * Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ≤ 1\n  * Corticosteroids: If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid\n  * Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (eg, pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: ≥ 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: ≥ 30 days\n  * Cellular therapy: ≥ 30 days after the completion of any type of cellular therapy (eg, modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.)\n  * Radiotherapy (XRT)\u002Fexternal beam irradiation including protons: ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial bone marrow (BM) radiation\n  * Radiopharmaceutical therapy (eg, radiolabeled antibody, lobenguane I-131 \\[131I-MIBG\\]): ≥ 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior Bcl-xL specific therapy (e.g. navitoclax, DT2216). Prior therapy with irinotecan or other topoisomerase 1 inhibitors and\u002For other BH3 mimetics which are not Bcl-xL selective (e.g. venetoclax) are acceptable\n* For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) ≥ 1000\u002FµL\n* For patients with solid tumors without known bone marrow involvement: Platelet count ≥ 100,000\u002FµL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* A creatinine based on age\u002Fgender as follows:\n\n  * 1 to \\\u003C 2 years: Maximum serum creatinine (mg\u002FdL) 0.6 (male), 0.6 (female)\n  * 2 to \\\u003C 6 years: Maximum serum creatinine (mg\u002FdL) 0.8 (male), 0.8 (female)\n  * 6 to \\\u003C 10 years: Maximum serum creatinine (mg\u002FdL) 1 (male), 1 (female)\n  * 10 to \\\u003C 13 years: Maximum serum creatinine (mg\u002FdL) 1.2 (male), 1.2 (female)\n  * 13 to \\\u003C 16 years: Maximum serum creatinine (mg\u002FdL) 1.5 (male), 1.4 (female)\n  * 16 to ≤ 39 years: Maximum serum creatinine (mg\u002FdL) 1.7 (male), 1.4 (female)\n\n    * OR a 24 hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2\n    * OR a glomerular filtration rate (GFR) ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard). Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* Patients with solid tumors: Bilirubin (sum of conjugated + unconjugated or total) ≤ 1.5 x upper limit of normal (ULN) for age\n* Patients with solid tumors: Alanine aminotransferase (ALT) ≤ 3 x ULN, unless attributed to tumor involvement then ALT ≤ 5 x ULN\n\n  * Note: For the purposes of this study the ULN for ALT is defined as 45 U\u002FL\n* Patients with solid tumors: Aspartate aminotransferase (AST) ≤ 3 x ULN, unless attributed to tumor involvement then AST ≤ 5 x ULN\n\n  * Note: For the purposes of this study the ULN for AST is defined as 50 U\u002FL\n* Patients with solid tumors: Albumin ≥ 2 g\u002FdL\n* Patients with solid tumors: International normalized ratio (INR) ≤ 2.5\n* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days. If needed, evaluate use of enzyme-inducing anticonvulsants\n* Nervous system disorders (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) resulting from prior therapy must be ≤ grade 2, with the exception of decreased tendon reflex (DTR). Patient with any grade of tendon reflex decrease are eligible\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (eg, male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control. Patients who could become pregnant should use highly effective contraception during therapy and for 6 months after the last irinotecan dose or 120 days after the last dose of DT2216, whichever is longer. Patients with partners who could become pregnant should use condoms during therapy and for 3 months after the last dose irinotecan or 120 days after the last dose of DT2216, whichever is longer\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who have received drugs that are strong inducers or inhibitors of CYP3A4 within 14 days prior to study enrollment are not eligible\n* Patients with lymphoma are excluded\n* Patients who have an uncontrolled infection are not eligible\n* Patients with grade ≥ 2 diarrhea at baseline are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible\n* Dedicated central nervous system (CNS) imaging is not required but patients with current active CNS metastasis whether symptomatic or discovered incidentally without clinical symptoms, are not eligible\n* Patients with grade \\> 2 corrected QT interval (i.e. electrocardiogram \\[EKG\\] showing corrected QT interval \\[QTc\\] \\> 480 ms) at baseline are not eligible\n* Surgical procedure\n\n  * Central line placement, open or core needle biopsy of sites other than liver: \\\u003C 2 days prior to enrollment.\n  * Open or laparoscopic biopsies or core needle biopsies of liver \\\u003C 7 days prior to enrollment.\n  * All other surgeries \\\u003C 14 days prior to enrollment",{"count":411,"type":21},81,[413,53],"PHASE1","This phase I\u002FII trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). DT2216 is an anti-apoptotic protein B-cell lymphoma-extra large targeted protein degrader. It may stop the growth of tumor cells by blocking Bcl-xL, a protein needed for tumor cell survival. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid repair and may kill tumor cells. Giving DT2216 in combination with irinotecan may be safe, tolerable, and\u002For effective in treating children, adolescents and young adults with relapsed or refractory solid tumors or fibrolamellar cancer.",[416,417,418,419,420,421,422,423,424],"Childhood Fibrolamellar Carcinoma","Recurrent Childhood Fibrolamellar Carcinoma","Recurrent Childhood Malignant Solid Neoplasm","Recurrent Fibrolamellar Carcinoma","Recurrent Malignant Solid Neoplasm","Refractory Childhood Fibrolamellar Carcinoma","Refractory Childhood Malignant Solid Neoplasm","Refractory Fibrolamellar Carcinoma","Refractory Malignant Solid Neoplasm",{"date":396,"type":32},{"date":427,"type":32},"2025-06-12",{"date":429,"type":21},"2031-12-30",{"name":38,"class":39},21,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":455},"100546927","phase-3-a-study-using-risk-factors-to-determine-treatment-for-children-with-favorable-histology-wilms-tumors-fhwt-100546927","NCT06401330","A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)","Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)","Inclusion Criteria:\n\n* Patients must be enrolled on APEC14B1 and consent to Part A - Eligibility Screening prior to enrollment on AREN2231.\n* Patients must be \\\u003C 30 years old at enrollment.\n* Patients with newly diagnosed Stage I-IV Favorable Histology Wilms Tumor confirmed by central review and with a qualifying Initial Stratum Assignment on APEC14B1.\n* Patients must receive a qualifying Initial Stratum Assignment on APEC14B1-REN by Day 14 post-diagnostic procedure (nephrectomy or biopsy), where that procedure is Day 0.\n\n  * Patients must enroll on AREN2231 by Day 14.\n  * Exceptions: If patient reaches Day 14 (post initial diagnostic nephrectomy or biopsy) without receiving an Initial Stratum Assignment on APEC14B1-REN, patient will not be eligible for enrollment on AREN2231 unless all required materials (reports and Case Report Forms and specimens) for an Initial Stratum Assignment arrived by Day 7, but an Initial Stratum Assignment was not completed by Day 14. In these circumstances, after obtaining appropriate protocol consent, the patient may proceed with treatment according to local institutional staging and enroll within 5 calendar days of notification of the central Initial Stratum Assignment being issued, only if the AREN2231 Initial Stratum Assignment is in agreement with any treatment already initiated. If the Initial Stratum Assignment is not in agreement with the local institution's assessment then the patient will be ineligible for AREN2231.\n* All sites must have sent or plan to send diagnostic tumor sample for molecular testing through a Clinical Laboratory Improvement Act (CLIA)-certified (or equivalent if outside of the United States \\[US\\]) laboratory that can detect Loss of Heterozygosity (LOH) of chromosome 1p AND 16q, and gain of chromosome 1q. Patients potentially eligible for mVLR must also have LOH of chromosome 11p15 included.\n\n  * Note: Patients are eligible for enrollment prior to obtaining these molecular testing results, and it is strongly recommended that patients are enrolled before these results are available. However, molecular results must be returned and uploaded to APEC14B1-REN for integration into risk stratification by the required timepoints (specific timelines vary by treatment arm). Patients who do not have molecular results available by the arm-specific timepoints may be taken off protocol therapy.\n* Patients who have an upfront nephrectomy must have at least one lymph node sampled and confirmed as a lymph node by central pathology review to be eligible.\n\n  * Note: Lymph node sampling will also be required at delayed nephrectomy. Patients who do not have a lymph node sampled and confirmed as a lymph node by central pathology review at delayed nephrectomy will be taken off protocol therapy.\n* Karnofsky performance status must be ≥ 50 for patients \\> 16 years of age and the Lansky performance status must be ≥ 50 for patients ≤ 16 years of age.\n* ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) OR direct bilirubin ≤ 3X ULN for subjects with total bilirubin levels \\> 1.5 ULN (within 7 days prior to enrollment).\n* ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Aspartate aminotransferase (AST\u002Fserum glutamate oxaloacetic transaminase \\[SGOT\\]) OR alanine transaminase (ALT\u002Fserum glutamic pyruvate transaminase \\[SGPT\\]) ≤ 3X ULN OR ≤ 5 X ULN for patients with liver metastases (within 7 days prior to enrollment).\n* ONLY TO PATIENTS WHO WILL RECEIVE CHEMOTHERAPY: Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% (within 7 days prior to enrollment)\n\n  * Note: This criteria only applies to patients centrally classified as Stage IV. Stage II and III patients subsequently assigned to a doxorubicin arm will be off protocol therapy if they do not meet this criteria at time of cardiac function assessment.\n* Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patient with a diagnosis of Stage V Bilateral Wilms Tumor.\n* Patients who in the opinion of the investigator are not able to comply with the study procedures are not eligible.\n* Patients with any uncontrolled, intercurrent illness including but not limited to symptomatic congestive heart failure.\n* Patients with Stage I FHWT with a known or suspected Wilms Tumor predisposition syndrome or condition (contralateral nephrogenic rests and\u002For unilateral multicentric tumors) are excluded from treatment on the mVLR (Nephrectomy Only) arm.\n\n  * Notes:\n\n    * In the context of the renal tumor protocols, multicentric tumors and multifocal tumors are equivalent terms, and refer to the occurrence of two or more tumors arising within one kidney.\n    * Exclusion from the Nephrectomy Only arm applies to two groups of patients:\n\n      * Patients \\\u003C 4 years with Stage I FHWT other than epithelial subtype AND\n      * Stage I patients of any age with Epithelial WT\n    * For the purpose of exclusion from the Nephrectomy Only Arm, known or suspected WT predisposition syndromes or conditions are defined as follows:\n\n      * WT Predisposition Syndromes: Beckwith Wiedemann Spectrum, Denys Drash, Trisomy 18, Idiopathic Hemihypertrophy\u002FIsolated Lateralized Overgrowth, WAGR, Simpson-Golabi-Behmel, Bohring-Opitz, or other conditions considered by treating physician to predispose to WT.\n      * WT Predisposing Conditions:\n\n        * A unilateral WT and (radiologic or pathologic) determination of contralateral nephrogenic rest(s) AND\u002FOR\n        * Unilateral multicentric WT\n* Patients treated with partial nephrectomy at initial diagnosis are excluded from mVLR (Nephrectomy Only) arm.\n* Patients with lung metastases as the only metastatic site who already had complete resection of all radiologically evident lung nodules, and have at least one nodule confirmed pathologically as tumor.\n\n  * Please note: Those with lung metastases as the only metastatic site who have complete resection of all radiologically evident lung nodules after enrollment but prior to the lung imaging following Cycle 2 of DD-4A will be inevaluable for lung assessment and subsequent stratum assignment and will, therefore, come off protocol therapy.\n* Patients with known Charcot-Marie-Tooth syndrome.\n* Patients who have had prior tumor-directed chemotherapy or radiotherapy for the current diagnosis except for therapy delivered for an emergent issue, as medically indicated.\n* Patients who will potentially require doxorubicin on this study and have previously received doxorubicin for another diagnosis.\n* Patients receiving concurrent chemotherapy for a different diagnosis.\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating females who plan to breastfeed their infants.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.","30 Years",{"count":441,"type":21},1656,[24],"This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term \"risk\" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.",[445,446,447,448],"Stage I Mixed Cell Type Kidney Wilms Tumor","Stage II Mixed Cell Type Kidney Wilms Tumor","Stage III Mixed Cell Type Kidney Wilms Tumor","Stage IV Mixed Cell Type Kidney Wilms Tumor",{"date":396,"type":32},{"date":451,"type":32},"2025-04-15",{"date":453,"type":21},"2031-02-13",{"name":38,"class":39},159,{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":463,"maxAge":122,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":474,"locationsCount":475},"100493938","phase-3-a-study-of-the-drug-letermovir-as-prevention-of-cytomegalovirus-infection-after-stem-cell-transplant-in-pediatric-patients-100493938","NCT05711667","A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients","Letermovir Prophylaxis for Cytomegalovirus in Pediatric Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* \\>= 2 years and \\\u003C 18 years at the time of enrollment\n* Weight must be \\>= 6 kg at the time of enrollment\n* Planned allogeneic HCT (bone marrow, peripheral blood stem cell, or cord blood transplant)\n* Patient must be CMV sero-positive (i.e., recipient CMV immunoglobulin G positive)\n\n  * Note: If a patient has hypogammaglobulinemia but has previously been documented as CMV sero-positive, that is acceptable for study inclusion. For all patients already confirmed to be CMV IgG seropositive, repeat testing is not required within 7 days prior to enrollment. However, the laboratory data determining eligibility must be available in the patient's medical\u002Fresearch record for verification\n* Patient is eligible for entry only if it is feasible for plasma CMV PCR testing to be sent and resulted within the protocol mandated time period\n\n  * Reminder: To limit the likelihood of positive plasma CMV PCR post-enrollment and prior to start of study treatment period, it is recommended that patient enrollment proceed after patients start their transplant preparative regimen\n* Patient must have a performance status corresponding to Lansky\u002FKarnofsky scores \\> 50\n\n  * Note: Use Lansky for patients =\\\u003C 16 years of age and Karnofsky for patients \\> 16 years of age. For further reference, see performance status scales scoring under the standard sections for protocols among protocol reference materials provided on the Children's Oncology Group (COG) member website: https:\u002F\u002Fmembers.childrensoncologygroup.org\u002Fprot\u002Freference\\_materials.asp\n* Estimated glomerular filtration rate \\> 10 mL\u002Fmin\u002F1.73 m\\^2 and not receiving dialysis\n* Direct bilirubin =\\\u003C 2 mg\u002FdL and serum glutamate-pyruvate transaminase (SPGT) (alanine transaminase \\[ALT\\]) =\\\u003C10 x upper limit of normal (ULN) for age\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n\nExclusion Criteria:\n\n* Expected inability to tolerate oral formulation of letermovir\n* Hypersensitivity to letermovir or any component of the formulation\n* History of CMV end organ disease within 6 months (180 days) prior to enrollment\n\n  * Note: CMV end organ disease based on proposed definitions by Ljungman et al. and inclusive of proven, probable or possible disease\n* Receipt of prior allogeneic HCT within one year of study enrollment\n* Planned prophylactic administration of other anti-CMV medications or cellular products during the study, including:\n\n  * High dose acyclovir (defined as doses \\>= 1500 mg\u002Fm\\^2 IV or \\>= 3200 mg oral (patients \\>= 40 kg) or \\>= 2400 mg\u002Fm\\^2 (patients \\\u003C 40 kg) per day)\n  * High dose valacyclovir (defined as doses \\>= 3000 mg\u002Fday in patients \\> 20 kg)\n  * Foscarnet\n  * Ganciclovir\n  * Valganciclovir\n  * CMV-directed cytotoxic T lymphocytes\n* Planned receipt of the following contraindicated medications during the study treatment period; contraindicated medications must be discontinued at least 14 days prior to Day +1\n\n  * Contraindicated medications for all patients:\n\n    * Pimozide\n    * Ergot alkaloids\n  * Contraindicated medications for patients planned to receive cyclosporine:\n\n    * Bosentan\n    * Pitavastatin\n    * Simvastatin\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted in certain animal reproduction studies with letermovir. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active female patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their letermovir treatment and through at least 4 weeks after the last dose of letermovir.\n\n  * Note: No contraception measures are needed specifically during letermovir treatment for male trial participants who have pregnant or non-pregnant female partner(s) of reproductive potential. Contraception measures may be required for other aspects of the HCT procedure.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","2 Years",{"count":465,"type":21},105,[24],"This phase III single arm trial determines whether taking prophylactic letermovir will reduce the likelihood of infection with cytomegalovirus (CMV) in children and adolescents after stem cell transplant compared to estimated rate of infection without prophylaxis. The treatments used to prepare for HCT reduce the body's natural infection-fighting ability and increase the likelihood of an infection with a virus called cytomegalovirus. \"Prophylaxis\" means to take a drug to prevent a disease or side effect. Letermovir is an antiviral drug that stops cytomegalovirus from multiplying and may prevent cytomegalovirus infection and make the disease less severe.",[469,175],"Hematopoietic and Lymphoid Cell Neoplasm",{"date":396,"type":32},{"date":472,"type":32},"2024-07-11",{"date":111,"type":21},{"name":38,"class":39},29,{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":483,"maxAge":168,"enrollmentInfo":484,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":495,"locationsCount":496},"100493245","a-study-to-learn-more-about-the-health-of-persons-with-down-syndrome-after-treatment-for-acute-leukemia-100493245","NCT05702645","A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia","Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)","Inclusion Criteria:\n\n* Patients age \\>= 6 and \\\u003C 40 years at the time of enrollment\n* A diagnosis of Down syndrome is required, and may include any of the three recognized types: trisomy 21 resulting from chromosomal nondisjunction (most common), translocation (the patient has 46 chromosomes, but all or part of an additional copy of chromosome 21 is attached to another chromosome), or mosaicism (trisomy 21 that is present in only a fraction of cells)\n* All patients must be DS-AL survivors (acute lymphoblastic leukemia \\[ALL\\] or acute myeloid leukemia \\[AML\\])\n\n  * Note 1: Myeloid leukemia of Down syndrome (ML-DS) is included in the AML category above. Per the World Health Organization (WHO) definition of ML-DS, this diagnosis encompasses both myelodysplastic syndrome (MDS) and overt AML. Also, note that survivors of relapsed disease are eligible, so long as the patient otherwise meets eligibility criteria, i.e., treatment for relapse was completed at least 36 calendar months prior to enrollment and did not include stem cell transplant\n  * Note 2: A diagnosis of transient abnormal myelopoiesis (TAM), also known as transient myeloproliferative disease (TMD), is not alone sufficient for inclusion in this study\n* Patients must have been treated for ALL or AML\n\n  * Note: History of COG therapeutic trial participation is not required. As a reminder ML-DS would be included under the AML category here above\n* All cancer treatment (oral or intravenous) must have been completed at least 36 calendar months prior to enrollment\n* Patients must have a life expectancy of \\> 1 year\n* Patient and parent of subject must be either English or Spanish speaking. At least one parent or guardian must be able to read and write in English or Spanish\n\n  * Note: Parents or guardians are responsible for completing all questionnaires, even in the case of subjects that are \\>= 18 years old\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n\nExclusion Criteria:\n\n* Patients with history of hematopoietic stem cell transplant (HSCT) are excluded\n\n  * Note: Patients with previous chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate, as long as all other eligibility criteria are satisfied\n* Patients with a history of cancers prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded\n\n  * Note: Prior history of transient abnormal myelopoiesis is allowed, but is not sufficient for eligibility\n* Patients whose parents or guardians are unable to complete the required forms are excluded","6 Years",{"count":485,"type":21},330,"This study attempts to learn more about the health of persons with Down syndrome after treatment for acute leukemia. Children with Down syndrome are at increased risk for side effects during treatment for acute leukemia, but it is unclear of their risk for long-term effects of cancer treatment. By learning more about the factors that may contribute to chronic health conditions and long-term effects after treatment for leukemia in persons with Down syndrome, clinical practice guidelines for survivorship care can be developed to help improve their quality-of-life.",[488,489,490],"B Acute Lymphoblastic Leukemia Associated With Down Syndrome","Down Syndrome","Myeloid Leukemia Associated With Down Syndrome",{"date":396,"type":32},{"date":493,"type":32},"2023-11-30",{"date":111,"type":21},{"name":38,"class":39},70,{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":49,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":505,"briefSummary":506,"conditions":507,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":517},"100462662","phase-3-chemotherapy-for-the-treatment-of-patients-with-newly-diagnosed-very-low-risk-and-low-risk-fusion-negative-rhabdomyosarcoma-100462662","NCT05304585","Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma","A Prospective Phase 3 Study of Patients With Newly Diagnosed Very Low-Risk and Low-Risk Fusion Negative Rhabdomyosarcoma","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 (NCT02402244) and consented to the Molecular Characterization Initiative (Part A) prior to enrollment and treatment on ARST2032 (this trial).\n* Patients must be =\\\u003C 21 years at the time of enrollment.\n* Patients must have newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell\u002Fsclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma (ARMS) (institutional FOXO1 fusion results are acceptable). RMS types included under ERMS include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell\u002Fsclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Enrollment in APEC14B1 is required for all patients.\n\n  * All patients will be evaluated for stage and clinical group. Note that clinical group designation assigned at the time of enrollment on study remains unchanged regardless of any second-look operation that may be performed.\n\n    * Patients will be eligible for the very low-risk stratum (Regimen VA) if they have Stage 1, CG I disease.\n    * Patients will be eligible for the low-risk stratum (Regimen VAC\u002FVA) if they have Stage 1, CG II disease, Stage 2, CG I or II disease, or Stage 1, CG III (orbit only) disease.\n  * Paratesticular Tumors: Staging ipsilateral retroperitoneal lymph node sampling (SIRLNS) is required for all patients \\>= 10 years of age with paratesticular tumors who do not have gross nodal involvement on imaging.\n  * Extremity Tumors: Regional lymph node sampling is required for histologic evaluation in patients with extremity tumors.\n  * Clinically or radiographically enlarged nodes must be sampled for histologic evaluation.\n* Patients must have a Lansky (for patients =\\\u003C 16 years of age) or Karnofsky (for patients \\> 16 years of age) performance status score of \\>= 50. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score.\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002FuL (within 7 days prior to enrollment).\n* Platelet count \\>= 75,000\u002FuL (transfusion independent) (within 7 days prior to enrollment).\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine (within 7 days prior to enrollment) based on age\u002Fgender as follows:\n\n  * Age: 1 month to \\\u003C 6 months; Maximum serum creatinine (mg\u002FdL): 0.4 (male) : 0.4 (female)\n  * Age: 6 months to \\\u003C 1 year; Maximum serum creatinine (mg\u002FdL): 0.5 (male) : 0.5 (female)\n  * Age: 1 to \\\u003C 2 years; Maximum serum creatinine (mg\u002FdL): 0.6 (male) : 0.6 (female)\n  * Age: 2 to \\\u003C 6 years; Maximum serum creatinine (mg\u002FdL): 0.8 (male) : 0.8 (female)\n  * Age: 6 to \\\u003C 10 years; Maximum serum creatinine (mg\u002FdL): 1 (male) : 1 (female)\n  * Age: 10 to \\\u003C 13 years; Maximum serum creatinine (mg\u002FdL): 1.2 (male) : 1.2 (female)\n  * Age: 13 to \\\u003C 16 years; Maximum serum creatinine (mg\u002FdL): 1.5 (male) : 1.4 (female)\n  * Age \\>= 16 years; Maximum serum creatinine (mg\u002FdL): 1.7 (male) : 1.4 (female)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment), and\n\n  * If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \\\u003C 3 x ULN for age.\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL.\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL\n\n  * If there is evidence of biliary obstruction by the tumor, then the total bilirubin must be \\\u003C 3 x ULN for age\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients who have received prior chemotherapy and\u002For radiation therapy for cancer prior to enrollment. Surgical resection alone of previous cancer(s) is permitted.\n* Patients who have received chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.\n* Vincristine is sensitive substrate of the CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.\n* Patients unable to undergo radiation therapy, if necessary, as specified in the protocol.\n* Evidence of uncontrolled infection.\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating females who plan to breastfeed their infants.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.",{"count":113,"type":21},[24],"Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.",[508,509,510],"Embryonal Rhabdomyosarcoma","Fusion-Negative Alveolar Rhabdomyosarcoma","Spindle Cell\u002FSclerosing Rhabdomyosarcoma",{"date":396,"type":32},{"date":513,"type":32},"2022-08-04",{"date":515,"type":21},"2030-06-30",{"name":38,"class":39},180,{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":525,"targetDuration":4,"studyType":22,"phases":527,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":536,"locationsCount":537},"100457328","phase-3-thoracotomy-versus-thoracoscopic-management-of-pulmonary-metastases-in-patients-with-osteosarcoma-100457328","NCT05235165","Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma","A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma","Inclusion Criteria:\n\n* Patients must be \\\u003C 50 years at the time of enrollment.\n* Patients must have =\\\u003C 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \\>= 3 mm and all of which must be =\\\u003C 3 cm size.\n\n  * Note: Patient must have eligibility confirmed by rapid central imaging review.\n* Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.\n* Patients must have a histological diagnosis of osteosarcoma.\n* Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.\n* Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.\n* Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.\n* Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.\n\nExclusion Criteria:\n\n* Patients with unresectable primary tumor.\n* Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as \"central\" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).\n* Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.\n* Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.\n* Patients with evidence of extrapulmonary metastatic disease.\n* Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.",{"count":526,"type":21},62,[24],"This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.",[530,531,368],"Metastatic Malignant Neoplasm in the Lung","Metastatic Osteosarcoma",{"date":396,"type":32},{"date":534,"type":32},"2022-04-01",{"date":36,"type":21},{"name":38,"class":39},232,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":545,"maxAge":49,"enrollmentInfo":546,"targetDuration":4,"studyType":22,"phases":548,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":562,"locationsCount":563},"100429351","phase-1-cbl0137-for-the-treatment-of-relapsed-or-refractory-solid-tumors-including-cns-tumors-and-lymphoma-100429351","NCT04870944","CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma","A Phase 1\u002F2 Trial of CBL0137 (NSC# 825802) in Patients With Relapsed or Refractory Solid Tumors Including CNS Tumors and Lymphoma","Inclusion Criteria:\n\n* Parts A and B: Patients must be \\>= 12 months and =\\\u003C 21 years of age at the time of study enrollment\n* Patients must have had histologic verification of malignancy at original diagnosis or relapse, except in patients with diffuse intrinsic brain stem tumors, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\n\n  * Part A: Patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases (including untreated or progressive) are eligible\n  * Part B: Patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27-altered DMG previously treated with radiation therapy\n* Part A: Patients must have either measurable or evaluable disease\n* Part B: Patients must have measurable disease\n* Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life\n* Patients must have a performance status corresponding to Easter Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age. Patients must have a Karnofsky or Lansky score \\>= 50%\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\n\n    * Solid tumor patients: \\>= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n  * Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): \\>= 7 days after the last dose of agent\n  * Antibodies: \\>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\\u003C 1\n  * Corticosteroids: If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid. Patients with CNS tumors receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment\n  * Hematopoietic growth factors: \\>= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \\>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \\>= 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: \\>= 30 days\n  * Cellular therapy: \\>= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.)\n  * Radiation therapy \\[XRT\\]\u002Fexternal beam irradiation including protons: \\>= 14 days after local XRT; \\>= 150 days after TBI, craniospinal XRT or if radiation to \\>= 50% of the pelvis; \\>= 42 days if other substantial bone marrow (BM) radiation\n  * Radiopharmaceutical therapy (e.g., radiolabeled antibody, I-131 metaiodobenzylguanidine \\[131I MIBG\\]): \\>= 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior exposure to CBL0137\n* For patients with solid tumors without known bone marrow involvement:\n\n  * Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (performed within 7 days prior to enrollment unless otherwise indicated)\n  * Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* For patients with solid tumors without known bone marrow involvement:\n\n  * Platelet count \\>= 100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (performed within 7 days prior to enrollment unless otherwise indicated)\n  * Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a creatinine based on age\u002Fsex as follows (performed within 7 days prior to enrollment unless otherwise indicated):\n\n  * Age: Maximum serum creatinine (mg\u002FdL)\n  * 1 to \\\u003C 2 years: 0.6 (male); 0.6 (female)\n  * 2 to \\\u003C 6 years: 0.8 (male); 0.8 (female)\n  * 6 to \\\u003C 10 years: 1 (male); 1 (female)\n  * 10 to \\\u003C 13 years: 1.2 (male); 1.2 (female)\n  * 13 to \\\u003C 16 years: 1.5 (male); 1.4 (female)\n  * \\>= 16 years: 1.7 (male); 1.4 (female)\n* Patients with solid tumors:\n\n  * Bilirubin (sum of conjugated + unconjugated or total) =\\\u003C 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment unless otherwise indicated)\n* Patients with solid tumors:\n\n  * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL (performed within 7 days prior to enrollment unless otherwise indicated)\n* Shortening fraction of \\>= 27% by echocardiogram (performed within 7 days prior to enrollment unless otherwise indicated) or\n* Ejection fraction of \\>= 50% by gated radionuclide study (performed within 7 days prior to enrollment unless otherwise indicated)\n* Corrected QT (QTC) \\\u003C 480 msec (performed within 7 days prior to enrollment unless otherwise indicated)\n* Patients with seizure disorder may be enrolled if seizures well controlled without the use of enzyme-inducing anti-convulsant agents. Well controlled is defined by no increase in seizure frequency in the prior 7 days\n* Nervous system disorders (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) resulting from prior therapy must be =\\\u003C grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible\n* Patients have consented to receive a central venous catheter prior to the administration of CBL0137. A central line is required for CBL0137 administration\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who are receiving drugs that are strong inducers or inhibitors of CYP3A4, CYP2B6 (e.g., carbamazepine) and CYP1A2 (e.g., ciprofloxacin, enoxacin, fluvoxamine, smoking) are not eligible. These agents are to be avoided for 7 days prior to the start of CBL0137 and for the duration of the protocol therapy. Sensitive substrates of CYP2D6 (e.g., atomoxetine, desipramine, dextromethorphan, eliglustat, nebivolol, nortriptyline, perphenazine, tolterodine, R-venlafaxine) should also be avoided for the duration protocol therapy\n* Patients who are receiving drugs associated with a known risk of Torsades de Pointes (TdP) are not eligible. Drugs associated with known risk of Torsades de Pointes (TdP) are to be avoided for 7 days prior to the start of CBL0137 and for duration of the protocol therapy\n* Patients with known peripheral vascular disease are excluded\n* Patients with a history of pro-thrombotic disorder are not eligible\n* Patients who have an uncontrolled infection are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible","12 Months",{"count":547,"type":21},63,[413,53],"This phase I\u002FII trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Drugs, such as CBL0137, block signals passed from one molecule to another inside a cell. Blocking these signals can affect many functions of the cell, including cell division and cell death, and may kill cancer cells.",[551,552,553,554,370,420,555,556,424,557],"Diffuse Midline Glioma, H3 K27-Altered","Metastatic Malignant Neoplasm in the Central Nervous System","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Diffuse Midline Glioma, H3 K27-Altered","Recurrent Primary Malignant Central Nervous System Neoplasm","Refractory Lymphoma","Refractory Primary Malignant Central Nervous System Neoplasm",{"date":396,"type":32},{"date":560,"type":32},"2022-01-28",{"date":378,"type":21},{"name":38,"class":39},35,{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":545,"maxAge":439,"enrollmentInfo":571,"targetDuration":4,"studyType":22,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":431},"100427831","phase-1-tegavivint-for-the-treatment-of-recurrent-or-refractory-solid-tumors-including-lymphomas-and-desmoid-tumors-100427831","NCT04851119","Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors","A Phase 1\u002F2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors","Inclusion Criteria:\n\n* PART A: Patients must be \\>= 12 months and =\\\u003C 21 years of age at the time of study enrollment\n* PART B: Patients must be \\>= 12 months and =\\\u003C 30 years of age at the time of study enrollment\n* Patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse\n* PART A: Patients with relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors\n* PART B: Patients with recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, and tumors with Wnt pathway aberrations. For the Wnt pathway aberrations cohort we will include the most common CTNNB1 mutations (S37F, S45F, T41A, S45P, S33C, S37C, D32Y, S33F, T41I, G34R, G34V, D32N, S33P, G34E, D32G) as well as any loss of function mutations in the APC, Axin2FBXW7, TCF7L2, and RNF43 genes or any gain-of-function mutations in the GSK3B, LRP6, and LGR5 genes. For patients without prior sequencing, immunohistochemistry (IHC), is required. IHC showing strong nuclear beta-catenin staining will be accepted for the following tumor types: colorectal carcinoma, melanoma, endometrial cancer, ovarian cancer, neuroblastoma, non-Hodgkin lymphoma, pancreatic ductal adenocarcinoma, and solid pseudopapillary tumor of the pancreas\n* PART A: Patients must have either measurable or evaluable disease. For desmoid tumors, the patient must have disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk\u002Fbenefit to the patient to participate in the trial\n* PART B: Patients must have measurable disease. For desmoid tumors, the patient must have measurable disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk\u002Fbenefit to the patient to participate in the trial\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\n\n    * Solid tumor patients: \\>= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n    * Non-Hodgkin lymphoma patients\n\n      * A waiting period prior to enrollment is not required for patients receiving standard maintenance chemotherapy (i.e., corticosteroid, vincristine, thioguanine \\[6MP\\], and\u002For methotrexate)\n      * \\>= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy\n      * NOTE: Cytoreduction with hydroxyurea must be discontinued \\>= 24 hours prior to the start of protocol therapy\n  * Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil counts \\[ANC\\]): \\>= 7 days after the last dose of agent\n  * Antibodies: \\>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\\u003C 1\n  * Corticosteroids: If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n  * Hematopoietic growth factors: \\>= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \\>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total-body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \\>= 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: \\>= 42 days.\n  * Cellular therapy: \\>= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.).\n  * External beam radiation therapy (XRT)\u002Fexternal beam irradiation including protons: \\>= 14 days after local XRT; \\>= 150 days after TBI, craniospinal XRT or if radiation to \\>= 50% of the pelvis; \\>= 42 days if other substantial bone marrow (BM) radiation\n  * Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 \\[131I MIBG\\]): \\>= 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior exposure to tegavivint\n* PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Platelet count \\>= 100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS WITHOUT KNOWN BONE MARROW INVOLVEMENT: Hemoglobin \\>= 8.0 g\u002FdL at baseline (may receive red blood cell \\[RBC\\] transfusions) (within 7 days prior to enrollment)\n* Patients with known bone marrow metastatic disease will be eligible for study provided they meet blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled on Part A must be evaluable for hematologic toxicity\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a creatinine based on age\u002Fgender as follows (within 7 days prior to enrollment):\n\n  * Age; maximum serum creatinine\n  * Age 1 to \\\u003C 2 years; 0.6 mg\u002FdL (male); 0.6 mg\u002FdL (female)\n  * Age 2 to \\\u003C 6 years; 0.8 mg\u002FdL (male); 0.8 mg\u002FdL (female)\n  * Age 6 to \\\u003C 10 years; 1 mg\u002FdL (male); 1 mg\u002FdL (female)\n  * Age 10 to \\\u003C 13 years; 1.2 mg\u002FdL (male); 1.2 mg\u002FdL (female)\n  * Age 13 to \\\u003C 16 years; 1.5 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n  * Age \\>= 16 years; 1.7 mg\u002FdL (male); 1.4 mg\u002FdL (female)\n* PATIENTS WITH SOLID TUMORS: Bilirubin (sum of conjugated + unconjugated or total) =\\\u003C 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS: Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL (within 7 days prior to enrollment)\n* PATIENTS WITH SOLID TUMORS: Albumin \\>= 2 g\u002FdL (within 7 days prior to enrollment)\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to the 1st dose of tegavivint to the end of the study\n* Patients who have received bisphosphonates within 4 weeks prior to study enrollment will be excluded\n* Patients who have received denosumab within 180 days prior to study enrollment will be excluded\n* Patients with primary brain tumors are ineligible\n* Patients with known central nervous system (CNS) metastasis, except for craniopharyngeal tumors, will be excluded\n* Patients with a known metabolic bone disease (ex: hyperparathyroidism, Paget's disease, osteomalacia) are not eligible\n* Patients with a disorder associated with abnormal bone metabolism will be excluded\n* Patients with grade \\>= 2 hypocalcemia that is not corrected with oral calcium supplementation will be excluded\n* Patients with vitamin D \\\u003C 20 ng\u002FmL will require supplementation, or will otherwise be excluded. Patients must agree to take vitamin D +\u002F- calcium supplements (if necessary) according to institutional or published guidelines. Additional calcium supplementation is not required if adequate dietary intake can be ascertained\n* Patients with pre-existing grade 3 osteoporosis are excluded\n* Patients who have an uncontrolled infection are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible",{"count":572,"type":21},147,[413,53],"This phase I\u002FII trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating patients with solid tumors that has come back (recurrent) or does not respond to treatment (refractory). Tegavivint interferes with the binding of beta-catenin to TBL1, which may help stop the growth of tumor cells by blocking the signals passed from one molecule to another inside a cell that tell a cell to grow.",[576,577,578,579,580,581,582,583,584,585,420,586,587,588,589,590,591,424,592,593,594,595],"Colorectal Carcinoma","Endometrial Carcinoma","Melanoma","Neuroblastoma","Ovarian Carcinoma","Pancreatic Ductal Adenocarcinoma","Recurrent Desmoid Fibromatosis","Recurrent Ewing Sarcoma","Recurrent Hepatoblastoma","Recurrent Hepatocellular Carcinoma","Recurrent Non-Hodgkin Lymphoma","Recurrent Osteosarcoma","Refractory Desmoid Fibromatosis","Refractory Ewing Sarcoma","Refractory Hepatoblastoma","Refractory Hepatocellular Carcinoma","Refractory Non-Hodgkin Lymphoma","Refractory Osteosarcoma","Solid Pseudopapillary Neoplasm of the Pancreas","Wilms Tumor",{"date":396,"type":32},{"date":598,"type":32},"2021-11-08",{"date":600,"type":21},"2028-06-30",{"name":38,"class":39},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":190,"maxAge":191,"enrollmentInfo":609,"targetDuration":4,"studyType":22,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":630},"100415034","phase-2-a-study-of-a-new-way-to-treat-children-and-young-adults-with-a-brain-tumor-called-nggct-100415034","NCT04684368","A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT","A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor","Inclusion Criteria:\n\n* Patients must be \\>= 3 years and \\\u003C 30 years at the time of study enrollment\n* Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and\u002For pineal region by pathology and\u002For serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or \\> 10 ng\u002FmL or human chorionic gonadotropin (hCG) beta \\> 100 mIU\u002FmL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 31 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy \\[repeat if necessary\\]). Basal ganglia or other primary sites are excluded\n* Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant\u002Fimmature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols)\n* Patients must have a cranial MRI with and without gadolinium at diagnosis\u002Fprior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 31 days prior to study enrollment and start of protocol therapy )\n* Patients must have a spine MRI with gadolinium obtained at diagnosis\u002Fprior to enrollment. Spine MRI with and without gadolinium is recommended (within 31 days prior to study enrollment and start of protocol therapy)\n* Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery\n* Patients must have RAPID CENTRAL TUMOR MARKER REVIEW CSF tumor markers obtained prior to enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy\u002Fsurgery are combined, CSF tumor markers should be collected first\n* Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (within 7 days prior to enrollment)\n* Platelet count \\>= 100,000\u002FuL (transfusion independent) (within 7 days prior to enrollment)\n* Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell \\[RBC\\] transfusions) (within 7 days prior to enrollment)\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine based on age\u002Fgender as follows (within 7 days prior to enrollment):\n\n  * Age: Maximum serum creatinine (mg\u002FdL)\n\n    * 3 to \\\u003C 6 years: 0.8 (male), 0.8 (female)\n    * 6 to \\\u003C 10 years: 1 (male), 1 (female)\n    * 10 to \\\u003C 13 years: 1.2 (male), 1.2 (female)\n    * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n    * \\>= 16 years: male (1.7), 1.4 (female)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL (within 7 days prior to enrollment)\n\n  * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U\u002FL\n* Central nervous system function defined as:\n\n  * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled\n  * Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment\n* Protocol therapy must begin within 31 calendar days of definitive surgery or clinical diagnosis, whichever is later. If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n* NEUROCOGNITIVE FUNCTION AND QUALITY OF LIFE ASSESSMENT:\n* English-, Spanish-, or French- speaking\n\n  * Note: Patients who speak a language other than English, Spanish, or French will be allowed to participate in ACNS2021 but will not complete the neurocognitive and quality of life assessments\n* No known history of neurodevelopmental disorder prior to diagnosis of NGGCT (e.g., Down syndrome, fragile X, William syndrome, intellectual disability). Patients with NF1 will be allowed to participate\n* Additional eligibility criteria for the COG Standardized Neuropsychological Battery only: must be at a site that has a psychologist to administer the battery\n\n  * Note: If not eligible for the COG Standardized Battery, patients should still complete the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2), Pediatric Quality of Life Inventory (PedsQL), Adaptive Behavior Assessment System Third Edition (ABAS-3), and Behavior Assessment System for Children, Third Edition (BASC-3) questionnaires\n\nExclusion Criteria:\n\n* Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus)\n* Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis\n* Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids\n* Patients with metastatic disease (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination)\n* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs\n\n  * Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation",{"count":610,"type":21},160,[53],"This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.",[614,615,616,617,618,619,620,621,622,623],"Central Nervous System Nongerminomatous Germ Cell Tumor","Choriocarcinoma","Embryonal Carcinoma","Immature Teratoma","Malignant Teratoma","Mixed Germ Cell Tumor","Pineal Region Germ Cell Tumor","Pineal Region Immature Teratoma","Pineal Region Yolk Sac Tumor","Suprasellar Germ Cell Tumor",{"date":396,"type":32},{"date":626,"type":32},"2021-07-13",{"date":628,"type":21},"2029-12-21",{"name":38,"class":39},166,{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":439,"enrollmentInfo":638,"targetDuration":4,"studyType":22,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":654},"100387252","phase-2-a-study-of-combination-chemotherapy-for-patients-with-newly-diagnosed-dawt-and-relapsed-fhwt-100387252","NCT04322318","A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT","Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)","Inclusion Criteria:\n\n* Patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on APEC14B1, consented to Part A - Eligibility Screening, and have received an initial stratum assignment showing DAWT (if anaplasia first identified at diagnostic, pre-treatment nephrectomy or biopsy) or a final stratum assignment showing DAWT (if anaplasia first noted at delayed nephrectomy) prior to enrollment on AREN1921. Prior enrollment on APEC14B1 is not an eligibility requirement for patients with relapsed favorable histology Wilms tumor.\n* Patients must be =\\\u003C 30 years old at study enrollment\n* Patients with the following diagnoses are eligible for this study:\n\n  * Newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor as confirmed by central review\n  * Favorable histology Wilms tumor at first relapse. Relapsed FHWT patients must have previously achieved remission for their initial FHWT diagnosis to be eligible for this study. The relapse risk groups are defined as follows, regardless of radiation therapy:\n\n    * Standard-Risk relapse: Patients who received two chemotherapy agents for frontline therapy; primarily actinomycin D and vincristine\n    * High-Risk relapse: Patients who received three chemotherapy agents for frontline therapy; primarily vincristine, actinomycin D and doxorubicin or vincristine, actinomycin D and irinotecan\n    * Very High-Risk relapse: Patients who received four or more chemotherapy agents as part of initial therapy; primarily regimen M or its variations\n* Patients with newly diagnosed DAWT must have had histologic verification of the malignancy. For relapsed FHWT patients, biopsy to prove recurrence is encouraged, but not required\n\n  * Note: For relapsed FHWT patients, an institutional pathology report confirming favorable histology Wilms tumor (from relapse, if available, or from original diagnosis) must be available for upload prior to initiation of protocol therapy\n* Patients with newly diagnosed Stages 2 - 4 diffuse anaplastic Wilms tumor must be enrolled on AREN1921 within 2 weeks of the tumor-directed surgery or biopsy procedure that first confirms a diagnosis of DAWT, whether at initial diagnostic procedure or delayed nephrectomy (such surgery\u002Fbiopsy is day 0). For patients who received prior therapy for presumed favorable histology Wilms tumor, later confirmed to have diffuse anaplastic Wilms tumor at subsequent review of the initial biopsy\n* Patients with newly diagnosed DAWT who undergo upfront nephrectomy must have at least 1 lymph node sampled prior to study enrollment\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n* Patients must have a life expectancy of \\>= 8 weeks\n* Diffuse Anaplastic Wilms Tumor: Patients with diffuse anaplastic histology must have had no prior systemic therapy, except in the following situations:\n\n  * Patients with diffuse anaplastic Wilms tumor who received no more than 12 weeks of pre nephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor, subsequently confirmed to be diffuse anaplastic Wilms tumor at delayed nephrectomy\n  * Patients with diffuse anaplastic Wilms tumor who received no more than 6 weeks of chemotherapy following upfront biopsy, initiated within 14 days of biopsy, for presumed favorable histology Wilms tumor based on institutional review, but subsequently corrected to diffuse anaplastic Wilms tumor based on the initial stratum assignment on APEC14B1-REN\n  * Treatment consisting of vincristine\u002Fdoxorubicin\u002Fcyclophosphamide initiated on an emergent basis and within allowed timing as described\n  * Note: Patients who received prior therapy for presumed favorable histology Wilms tumor, later identified to have diffuse anaplastic Wilms tumor as per above, must begin study treatment starting at cycle 3 (week 7) of regimen UH 3. Patients who received emergency radiation to preserve organ function are eligible as noted. Patients who received radiation as part of standard of care for presumed newly diagnosed favorable histology Wilms tumor, along with chemotherapy as noted above, prior to identification of diffuse anaplasia, are also eligible\n* Relapsed Favorable Histology Wilms Tumor: Patients must not have received prior chemotherapy for their relapsed favorable histology Wilms tumor diagnosis. In addition, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\n\n  * Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study\n  * Radiation therapy (RT): \\>= 2 weeks (wks) must have elapsed for local palliative RT (small port); \\>= 6 months must have elapsed if prior craniospinal RT or if \\>= 50% radiation of pelvis; \\>= 6 wks must have elapsed if other substantial bone marrow (BM) radiation. Patients with relapsed favorable histology Wilms tumor who received emergency radiation to preserve organ function are eligible and do not need to washout with the above criteria\n* Patients may not be receiving any other investigational agents (within 4 weeks prior to study enrollment)\n* Peripheral absolute neutrophil count (ANC) \\>= 750\u002FuL (performed within 7 days prior to enrollment)\n* Platelet count \\>= 75,000\u002FuL (transfusion independent) (performed within 7 days prior to enrollment)\n* Hemoglobin \\>= 8.0 g\u002FdL (may receive red blood cell \\[RBC\\] transfusions) (performed within 7 days prior to enrollment)\n* Patients with high-risk or very high-risk relapsed FHWT who will be treated with regimen ICE\u002FCyclo\u002FTopo, must have renal function assessed by creatinine clearance or radioisotope glomerular filtration rate (GFR) and meet the following requirement:\n\n  * Creatinine clearance or radioisotope GFR \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 (performed within 7 days prior to enrollment)\n* Patients diagnosed with stage 2-4 DAWT or standard risk relapsed FHWT, who will be treated with regimen UH 3, may either obtain a creatinine clearance, radioisotope GFR (meeting the above criteria of GFR \\>= 60 mL\u002Fmin\u002F1.73 m\\^2), or an adequate serum creatinine as per the following table:\n\n  * Age: Maximum Serum Creatinine (mg\u002FdL)\n  * 1 month to \\\u003C 6 months: 0.4 (male and female)\n  * 6 months to \\\u003C 1 year: 0.5 (male and female)\n  * 1 to \\\u003C 2 years: 0.6 (male and female)\n  * 2 to \\\u003C 6 years: 0.8 (male and female)\n  * 6 to \\\u003C 10 years: 1 (male and female)\n  * 10 to \\\u003C 13 years: 1.2 (male and female)\n  * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n  * \\>= 16 years: 1.7 (male), 1.4 (female)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age or direct bilirubin =\\\u003C ULN for patients whose total bilirubin \\> 1.5 x ULN (performed within 7 days prior to enrollment)\n* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) \\\u003C 2.5 x upper limit of normal (ULN) for age or =\\\u003C 5 x ULN for patients with liver metastases (performed within 7 days prior to enrollment)\n* Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by radionuclide angiogram (obtained within 21 days prior to enrollment and start of protocol therapy)\n\nExclusion Criteria:\n\n* Patients with a history of bilateral Wilms tumor (synchronous or metachronous)\n* Patients with any uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, or symptomatic congestive heart failure (defined as grade 2 or higher heart failure per Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0)\n* Relapsed FHWT patients who did not receive frontline chemotherapy (e.g., very low risk FHWT initially observed without chemotherapy) or received only one chemotherapy agent for frontline therapy\n* For patients with high-risk or very high-risk relapsed FHWT:\n\n  * Patients with renal tubular acidosis (RTA) as evidenced by serum bicarbonate \\\u003C 16 mmol\u002FL and serum phosphate =\\\u003C 2 mg\u002FdL (or \\\u003C 0.8 mmol\u002FL) without supplementation\n* For stages 2-4 DAWT and standard-risk relapsed FHWT patients:\n\n  * Chronic inflammatory bowel disease and\u002For bowel obstruction\n  * Concomitant use of St. John's wort, which cannot be stopped prior to the start of trial treatment\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation",{"count":639,"type":21},256,[53],"This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE\u002FCyclo\u002FTopo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and\u002For bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE\u002FCyclo\u002FTopo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).",[643,644,645,646,647],"Anaplastic Kidney Wilms Tumor","Recurrent Kidney Wilms Tumor","Stage II Kidney Wilms Tumor","Stage III Kidney Wilms Tumor","Stage IV Kidney Wilms Tumor",{"date":396,"type":32},{"date":650,"type":32},"2020-10-19",{"date":652,"type":21},"2027-07-01",{"name":38,"class":39},204,""]