[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epithelioid-sarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epithelioid-sarcoma":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,82,121,138,166,196,220],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":68,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":5},"100534472","phase-1-nrsts2021-a-risk-adapted-study-evaluating-maintenance-pazopanib-limited-margin-dose-escalated-radiation-therapy-and-selinexor-in-non-rhabdomyosarcoma-soft-tissue-sarcoma-nrsts-100534472",false,"NCT06239272","NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)","Inclusion Criteria:\n\nInclusion Criteria - All Patients\n\n* Patients must be 1-30 years at the time of the biopsy that established the diagnosis of NRSTS.\n* Surgical Resection: Patients who had an upfront resection prior to enrollment will be eligible if they are able to begin therapy within 28 days of resection assuming other eligibility criteria are met. Delayed resection is preferred for all patients with intermediate and high-risk disease.\n* Lansky performance status score ≥ 60 for patients ≤ 16 years of age. Karnofsky performance status score ≥ 60 for patients \\>16 years of age. Note 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 the performance score.\n\nDiagnosis\n\n• Patients with CIC-DUX 4 rearranged sarcomas will be enrolled on the high-risk stratum only, regardless of presence of metastasis, size, or resection status.\n\nPatient has low-risk disease if the patient has a:\n\n* Low-grade tumor of any size where R0 or R1 surgical margins are anticipated or achieved.\n* High-grade tumors that are \\\u003C 5 cm where R0 or R1 resection margins are anticipated or achieved.\n\nPatient must have adequate organ function in the organs that will be within the radiotherapy field.\n\nAdequate renal function defined as:\n\n* Creatinine clearance or radioisotope GFR \\> 70 mL\u002Fmin\u002F1.73 m2, or\n* A normal serum creatinine based on age\u002Fgender as follows\n\nAge Maximum Serum Creatinine (mg\u002FdL) Male Female 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4 \\> 16 years 1.5 1.4\n\nAdequate liver function defined as:\n\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) for age\n* SGOT (AST) or SGPT (ALT) \\\u003C 2.5 x ULN for age\n\nAdequate cardiac function defined as:\n\n* Ejection fraction of \\> 55% by echocardiogram or cardiac MRI\n* QTc \\\u003C 480 msec\n\nAdequate pulmonary function defined as:\n\n* No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \\> 94% on room air if there is clinical indication for determination.\n\nInclusion Criteria - Intermediate and High Risk Participants\n\nPatient has intermediate-risk if the patient has a:\n\n* Low-grade non-metastatic initially unresectable disease at study enrollment where delayed resection is planned.\n* High-grade \\\u003C 5 cm non-metastatic initially unresectable disease at study enrollment where delayed resection is planned. Of note, patients enrolled on the low-risk arm who were unable to achieve gross total resection where delayed re-resection is planned are eligible for this arm.\n* High-grade tumor \\> 5 cm that is potentially resectable.\n\nPatient high-risk if the patient has:\n\n* Metastatic disease at presentation\n* Unresectable disease at study enrollment where delayed resection is not anticipated. Of note, patients enrolled on the low-risk arm who were unable to achieve gross total resection where delayed re-resection is not-planned are eligible for this arm.\n* CIC-DUX4 rearranged sarcoma\n\nOrgan Function\n\nAdequate bone marrow function defined as:\n\n* Absolute neutrophil count \\> 1000\u002FµL\n* Platelet count \\> 100,000\u002FµL\n* Hemoglobin \\> 8 g\u002FdL for patients \\\u003C 16 years of age\n* Hemoglobin \\> 9 g\u002FdL for patients \\> 16 years of age\n\nNote: No transfusions are permitted 7 days prior to laboratory studies to determine eligibility.\n\nAdequate renal function defined as:\n\n* Creatinine clearance or radioisotope GFR \\> 70 mL\u002Fmin\u002F1.73 m2, or\n* A normal serum creatinine based on age\u002Fgender as follows\n\nAge Maximum Serum Creatinine (mg\u002FdL) Male Female 2 to \\\u003C 6 years 0.8 0.8 6 to \\\u003C 10 years 1 1 10 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4 \\> 16 years 1.5 1.4\n\nAdequate liver function defined as:\n\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) for age\n* SGOT (AST) or SGPT (ALT) \\\u003C 2.5 x ULN for age\n\nAdequate cardiac function defined as:\n\n* Ejection fraction of \\> 55% by echocardiogram or cardiac MRI\n* QTc \\\u003C 480 msec\n\nAdequate pulmonary function defined as:\n\n* No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \\> 94% on room air if there is clinical indication for determination.\n\nAnticoagulation\n\nPatients on low molecular weight heparin, warfarin (with a stable INR), or direct oral anticoagulants (DOAC) who have been on a stable dose of are eligible. Patients being treated for a pulmonary embolism or deep venous thrombosis (DVT) must have been treated for a minimum of 6 weeks prior to starting therapy treatment.\n\nLife Expectancy\n\nPatient must have a life expectancy of at least 3 months with appropriate therapy.\n\nExclusion Criteria:\n\n* Patients with known primary CNS sarcoma or CNS metastases are not eligible. Note: Brain imaging is not an eligibility requirement. Tumors with intracranial extension will be allowed.\n* Patients with the following histologic diagnosis are not eligible: intermediate locally aggressive tumors as defined by WHO, malignant rhabdoid tumor, alveolar soft part sarcoma, infantile fibrosarcoma, unresectable\u002Fmetastatic dermatofibrosarcoma protuberans, inflammatory myofibroblastic tumor, desmoid fibromatosis, rhabdomyosarcoma, desmoplastic small round cell tumor, BCOR-CCNB3 fusion positive sarcoma.\n* Bleeding diathesis: Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: Patients aged \\> 17 years with excess of 2.5 mL of hemoptysis are not eligible).\n* Uncontrolled hypertension: Patients with uncontrolled hypertension (CTCAE v5 Grade ≥ 2) are ineligible. Hypertension must be well controlled on stable doses of medication for at least two weeks.\n\nPrior Therapy\n\n* Patients must have had no prior systemic therapy for the treatment of the NRSTS\n* Patients must have had no prior anthracycline or ifosfamide chemotherapy\n* Patients must have had no prior use of pazopanib or similar multi-targeted TKI.\n\nPatients must have had no prior radiotherapy to tumor-involved sites.\n\nNote: Patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded.\n\n* CYP3A4 Substrates WITH Narrow Therapeutic Indices: Patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible. Note: the use of fentanyl is permitted.\n* CYP3A4 Inhibitors: Patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin, many NNRTIs, diltiazem, verapamil, and grapefruit juice are not eligible.\n* CYP3A4 Inducers: Patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids).\n* Certain medications that are associated with a risk for QTc prolongation and\u002For Torsade's de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible.\n* Subjects with any condition that may impair the ability to absorb oral medications\u002Finvestigational product including:\n\n  * prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel\n  * active peptic ulcer disease\n  * malabsorption syndrome\n\n3.4.12 Thyroid Replacement Therapy: Patients who require thyroid replacement therapy are not eligible if they have not been receiving a stable replacement dose for at least 4 weeks prior to study enrollment.\n\n3.4.13 Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:\n\n* active peptic ulcer disease\n* known intraluminal metastatic lesions\n* inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation\n* history of abdominal fistula, gastrointestinal perforation or intra- abdominal abscess within 28 days prior to beginning study treatment.\n\n3.4.14 Pulmonary embolism or DVT. Patients must not have experienced:\n\n* An untreated pulmonary embolism or DVT in last 6 months or\n* treated pulmonary embolism or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks\n* arterial thrombosis in last 12 months\n\nHistory of serious or non-healing wound, ulcer, or bone fracture.\n\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nHIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pazopanib. In addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n\nPatients who are receiving any other investigational agent(s).\n\nPregnancy and Breast Feeding\n\n* Pregnancy and Breast Feeding Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies.\n* Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment.\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.\n* Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential.","ALL","30 Years",{"count":18,"type":19},139,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS).\n\nPrimary Objectives\n\nIntermediate-Risk\n\n* To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin, pazopanib, surgery, and maintenance pazopanib, with or without RT.\n* To characterize the pharmacokinetics of pazopanib and doxorubicin in combination with ifosfamide in intermediate-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and pazopanib and doxorubicin pharmacokinetics.\n\nHigh-Risk\n\n* To estimate the maximum tolerated dose (MTD) and\u002For the recommended phase 2 dosage (RP2D) of selinexor in combination with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib in high-risk participants.\n* To characterize the pharmacokinetics of selinexor, pazopanib and doxorubicin in combination with ifosfamide in high-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and selinexor, pazopanib and doxorubicin pharmacokinetics.\n\nSecondary Objectives\n\n* To estimate the cumulative incidence of primary site local failure and distant metastasis-free, disease-free, event-free, and overall survival in participants treated on the risk-based treatment strategy defined in this protocol.\n* To define and describe the CTCAE Grade 3 or higher toxicities, and specific grade 1-2 toxicities, in low- and intermediate-risk participants.\n* To study the association between radiation dosimetry in participants receiving radiation therapy and the incidence and type of dosimetric local failure, normal adjacent tissue exposure, and musculoskeletal toxicity.\n* To evaluate the objective response rate (complete and partial response) after 3 cycles for high-risk patients receiving the combination of selinexor with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib.\n* To assess the relationship between the pharmacogenetic variation in drug-metabolizing enzymes or drug transporters and the pharmacokinetics of selinexor, pazopanib, and doxorubicin in intermediate- or high-risk patients.\n\nExploratory Objectives\n\n* To explore the correlation between radiographic response, pathologic response, survival, and toxicity, and tumor molecular characteristics, as assessed through next-generation sequencing (NGS), including whole genome sequencing (WGS), whole exome sequencing (WES), and RNA sequencing (RNAseq).\n* To explore the feasibility of determining DNA mutational signatures and homologous repair deficiency status in primary tumor samples and to explore the correlation between these molecular findings and the radiographic response, survival, and toxicity of patients treated on this protocol.\n* To explore the feasibility of obtaining DNA methylation profiling on pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to assess the correlation with this and pathologic diagnosis, tumor control, and survival outcomes where feasible.\n* To explore the feasibility of obtaining high resolution single-cell RNA sequencing of pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to characterize the longitudinal changes in tumor heterogeneity and tumor microenvironment.\n* To explore the feasibility of identifying characteristic alterations in non-rhabdomyosarcoma soft tissue sarcoma in cell-free DNA (cfDNA) in blood as a non-invasive method of detecting and tracking changes during therapy, and to assess the correlation of cfDNA and mutations in tumor samples.\n* To describe cardiovascular and musculoskeletal health, cardiopulmonary fitness among children and young adults with NRSTS treated on this protocol.\n* To investigate the potential prognostic value of serum cardiac biomarkers (high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro B-type natriuretic peptide (NT-Pro-BNP), serial electrocardiograms (EKGs), and serial echocardiograms in patients receiving ifosfamide, doxorubicin, and pazopanib, with or without selinexor.\n* To define the rates of near-complete pathologic response (\\>90% necrosis) and change in FDG PET maximum standard uptake value (SUVmax) from baseline to week 13 in intermediate risk patients with initially unresectable tumors treated with induction pazopanib, ifosfamide, and doxorubicin, and to correlate this change with tumor control and survival outcomes.\n* To determine the number of high-risk patients initially judged unresectable at diagnosis that are able to undergo primary tumor resection after treatment with ifosfamide, doxorubicin, selinexor, and pazopanib.\n* To identify the frequency with which assessment of volumes of interest (VOIs) of target lesions would alter RECIST response assessment compared with standard linear measurements.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67],"Adipocytic Neoplasm","Liposarcoma","Atypical Fibroxanthoma","Angiomatoid Fibrous Histiocytoma","Fibrosarcoma NOS","Myxofibrosarcoma","Angiosarcoma","Osteosarcoma, Extraskeletal","Dedifferentiated Liposarcoma","Myxoid Liposarcoma","Pleomorphic Liposarcoma","Myxoid Pleomorphic Liposarcoma","Low Grade Fibromyxoid Sarcoma","Sclerosing Epithelioid Fibrosarcoma","Malignant Tenosynovial Giant Cell Tumor of Soft Tissue","Epithelioid Hemangioendothelioma","Glomus Tumor","Inflammatory Leiomyosarcoma","Leiomyosarcoma","Ossifying Fibromyxoid Tumor, Malignant","Myoepithelioma","Synovial Sarcoma","Epithelioid Sarcoma","Perineurioma, Malignant","Clear Cell Sarcoma","Extraskeletal Myxoid Chondrosarcoma","Granular Cell Tumor, Malignant","Melanotic Malignant Nerve Sheath Tumor","Malignant Peripheral Nerve Sheath Tumor","Perivascular Epithelioid Tumor, Malignant","Intimal Sarcoma","Myoepithelial Carcinoma","Undifferentiated Sarcoma","Pleomorphic Sarcoma, Undifferentiated","Round Cell Sarcoma, Undifferentiated","NTRK-Rearranged Spindle Cell Neoplasm","Phosphaturic Mesenchymal Tumor, Malignant","Round Cell Sarcoma","Well Differentiated Liposarcoma","Giant Cell Tumor of Soft Parts NOS","Low Grade Myofibroblastic Sarcoma","Dermatofibrosarcoma Protuberans, Fibrosarcomatous",[69],"Proton therapy","RECRUITING","2026-07-31",{"date":73,"type":74},"2026-08-03","ACTUAL",{"date":76,"type":74},"2024-03-27",{"date":78,"type":19},"2037-06",{"name":80,"class":81},"St. Jude Children's Research Hospital","OTHER",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":15,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":20,"phases":93,"briefSummary":94,"conditions":95,"keywords":107,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100564132","phase-1-alphabeta-t-and-b-cell-depletion-with-zoledronic-acid-for-solid-tumors-100564132","NCT06625190","Alpha\u002FBeta T and B Cell Depletion With Zoledronic Acid for Solid Tumors","Allogeneic Stem Cell Transplantation Utilizing Alpha\u002FBeta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed\u002FRefractory Solid Tumors","Inclusion Criteria:\n\n* Patients 6 months to ≤ 25 years old\n* Relapsed\u002FRefractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer \\>20% chance of cure with the following diseases:\n\n  1. neuroblastoma (high risk with relapsed or refractory disease),\n  2. relapsed\u002Frefractory rhabdomyosarcoma,\n  3. relapsed\u002Frefractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),\n  4. High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,\n  5. Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor\n  6. relapsed\u002Frefractory bone tumors: osteosarcoma and Ewing sarcoma\u002FPNET, or\n  7. Wilm's tumor or other high-risk solid tumors with \\\u003C10% expected survival with conventional treatment.\n* Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included.)\n* Haplo-identical related donor (at least one full haplotype must be matched).\n* Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \\>16 years of age and Lansky scores for patients ≤16 years of age\n* Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:\n\n  1. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.\n  2. Renal: Creatinine clearance or radioisotope GFR ≥60 mL\u002Fmin\u002F1.73 m2 or a serum creatinine based on age\u002Fgender\n  3. Cardiac: Ejection fraction of ≥ 40% by echocardiogram or radionuclide scan (MUGA).\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Individuals of childbearing potential (IOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for one year following transplantation to minimize the risk of pregnancy. Prior to study enrollment, individuals of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factor for an unintentional pregnancy.\n* Subjects with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for one year following stem cell transplantation.\n\nExclusion Criteria:\n\n* Patients with documented uncontrolled infection at the time of study entry are not eligible.\n\n  a. Uncontrolled infection is patient without treatment antimicrobials and\u002For demonstrating progression despite antimicrobials\n* Patients with progressive solid tumor disease after relapsed\u002Frefractory treatment.\n* Demonstrated lack of compliance with medical care, as determined by the treating physician.\n* Patients who have received an allogeneic HSCT within 6 months.\n* Patients who do not have an eligible allogeneic donor available.\n* Patients with a life expectancy \\\u003C3 months\n* Patients not meeting inclusion criteria for organ function.\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one year after transplantation.\n* Females who are known to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","6 Months","25 Years",{"count":92,"type":19},27,[22,23],"Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.\n\nWhile solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.\n\nBy utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed\u002Frefractory solid tumors and promote an improved event-free survival and overall survival.\n\nThis study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.",[96,97,47,98,50,99,100,101,102,48,103,104,105,106],"Neuroblastoma","Rhabdomyosarcoma","Peripheral Nerve Sheath Tumors","Alveolar Soft Part Sarcoma","Desmoplastic Small Round Cell Tumor","Chordoma","Rhabdoid Tumor","Myoepithelial Tumor","Osteosarcoma","Ewing Sarcoma","Wilms Tumor",[108,109,110],"pediatric solid tumors","stem cell transplantation","graft manipulation","2026-06-25",{"date":113,"type":74},"2026-06-30",{"date":115,"type":74},"2026-02-11",{"date":117,"type":19},"2030-02",{"name":119,"class":81},"University of Florida",1,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":4,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":4,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":127,"phases":4,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":135,"locationsCount":4},"100631594","compassionate-use-of-ubamatamab-100631594","NCT07502716","Compassionate Use of Ubamatamab","Eligibility will be determined during the application review process.","EXPANDED_ACCESS","Provide Compassionate Use of Ubamatamab",[130,48],"Renal Medullary Carcinoma (RMC)","AVAILABLE","2026-03-24",{"date":134,"type":74},"2026-03-31",{"name":136,"class":137},"Regeneron Pharmaceuticals","INDUSTRY",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":15,"minAge":145,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":20,"phases":148,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100360033","multimodal-immune-characterization-of-rare-soft-tissue-sarcoma---miras-project-from-sarra-sarcome-rare-project-of-the-french-sarcoma-group-100360033","NCT03967834","Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group","MIRAS","Inclusion Criteria:\n\n1. Age ≥18 years at the time of study entry.\n2. Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:\n\n   * Clear Cell Sarcoma (CCS)\n   * Epithelioid Sarcoma (ES)\n   * Perivascular Epithelioid Cell neoplasm (PEComa)\n   * Desmoplastic Small Round Cell Tumours (DSRCT)\n   * Malignant Solitary Fibrous Tumours (mSFT)\n   * Alveolar Soft Part Sarcoma (ASPS)\n   * Epithelioid Hemangioendothelioma (EH)\n   * Low-Grade Fibromyxoid Sarcoma (LGFS)\n   * Sclerosing Epithelioid Fibrosarcoma (SEF).\n3. Localized\u002Flocally advanced or metastatic disease.\n4. In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).\n5. In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.\n6. Patient followed in the center within a standard of care procedure or clinical trial.\n7. Archived tumor specimen at initial diagnosis available (before treatment initiation).\n8. Evaluable disease (measurable as per RECIST 1.1) or not.\n9. ECOG Performance status 0-3.\n10. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.\n11. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Diagnosis of all other histotypes of soft tissue sarcoma.\n2. Any condition contraindicated with procedures required by the protocol.\n3. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.\n5. Pregnant or breast-feeding woman.\n6. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship.","18 Years",{"count":147,"type":19},400,[149],"NA","This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.\n\n400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.\n\nRetrospective cases of patients (100 cases in total) will be identified in all centers through the GSF\u002FGETO clinical databases already setted up (including the clinical base Conticabase).",[152,50,48,153,100,154,99,41,38,39],"Soft Tissue Sarcoma","Perivascular Epithelioid Cell Neoplasms","Malignant Solitary Fibrous Tumors",[152,50,48,153,100,154,99,41,38,39],"2026-02-09",{"date":158,"type":74},"2026-02-10",{"date":160,"type":74},"2021-04-26",{"date":162,"type":19},"2031-04",{"name":164,"class":81},"Institut Claudius Regaud",20,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":15,"minAge":145,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":20,"phases":175,"briefSummary":176,"conditions":177,"keywords":181,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100392493","phase-1-evaluate-the-safety-and-clinical-activity-of-hh2853-100392493","NCT04390737","Evaluate the Safety and Clinical Activity of HH2853","A Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853 in Patients With Relapsed\u002FRefractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors","Inclusion criteria:\n\n1. Provided signed written informed consent prior to initiation of any study-related procedures;\n2. Males and females ≥ 18years of age at the time of consent are obtained (or meet the country's regulatory defined adult legal age);\n3. Tumor type criteria:\n\nThe specific requirements for specific subtypes of recurrent\u002Frefractory non Hodgkin's lymphoma (NHL) confirmed by histology are as follows:\n\nHistologically confirmed follicular lymphoma (FL) that has been treated with at least two lines of systemic therapy (at least one regimen based on anti-CD20 monoclonal antibodies) according to GELF criteria or as determined by researchers (Grade 1-3a); Relapsed\u002Frefractory diffuse large B-cell lymphoma - non-specific (DLBCL NOS, 2016 World Health Organization Lymphoma Classification) that has received at least two treatment regimens in the past (at least one with CD20 monoclonal antibody as the main treatment, with a maximum number of treatment lines\\\u003C5), and is not a candidate for salvage treatment or autologous\u002Fallogeneic stem cell transplantation.\n\nRelapsed\u002Frefractory clinicopathologically documented PTCL with at least 1 line of prior systemic treatment (maximum \\\u003C5 lines). Solid tumors that meet the following criteria:\n\n1. Histologically or cytologically documented advanced recurrent or metastatic solid tumor.\n2. Phase I dose escalation: Measurable or evaluable lesions by RECIST v1.1 in at least 1 site; phase I dose extension and phase II: Measurable target lesions by RECIST v1.1 in at least 1 site. (Lesions that have been treated with radiotherapy or other local treatment are generally considered unmeasurable unless there is definite progression of the lesion.)\n3. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. One of the following criteria should be met.\n\nPatients must experience at least one prior standard therapy. Disease progression occurred on or after last line of therapy, or intolerant to last line of therapy (maximum ≤3 lines, Patients without treatment options available known to provide clinical benefit are also eligible upon agreement from investigator and sponsor) There is no approved therapy, or for which standard therapy is unsuitable or refused by patients after being fully informed.\n\nFor epithelioid sarcoma in Phase I and Phase II cohort 2:\n\n1. Confirmed by local histology or cytology\n2. Patients with unresectable locally delayed or metastatic epithelioid sarcoma who have undergone treatment (including those who have failed treatment and developed intolerable toxicity).\n\nFor solid tumors in Phase I and Phase II queue 3:\n\n1. Confirmed by local pathology as advanced recurrent or metastatic solid tumor.\n2. Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1; 5. Availability of archival tissue within three years 6. Relapsed\u002FRefractory FL, Epithelioid sarcoma, relapsed\u002Frefractory PTCL, other relapsed\u002Frefractory non-Hodgkin's lymphomas with EZH2 mutation, and advanced solid tumors with specific genetic alterations, including EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or\u002Fand SMARCA4 mutation 7. Predicted life expectancy of ≥ 3 months; 8. Patient must meet the following laboratory values: 1.Serum total Bilirubin ≤ 1.5 x ULN or ≤ 3.0 mg\u002FdL for patients with Gilbert's syndrome 2.AST\u002FSGOT and ALT\u002FSGPT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present 3.24-hour creatinine clearance (calculated\\* or measured value\\*\\*)≥ 50 mL\u002Fmin 4.Platelets ≥ 1 x LLN (no Platelet transfusion for 7 days prior to screening) 5.Hemoglobin (Hgb) ≥ 9 g\u002FdL 6.Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\\^9\u002FL 7.Adequate coagulation function: International normalized ratio (INR) \\\u003C1.3 (or \\\u003C3.0 on anticoagulants) 9. Measurable lesion\n\nExclusion Criteria:\n\n1. Any cancer-directed therapy within 28 days or five half-lives prior to first dose; Small molecule anticancer therapy within 2 weeks or five half-lives; Local radiotherapy within 14 days of first dose.\n2. Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.\n3. Patients with prior transplant are excluded;\n4. Major surgery within 4 weeks prior to first dose;\n5. A prohibited medication or expected to require any of these medications during treatment with study drug within 2 weeks of first dose;\n6. HIV (human immunodeficiency virus) infection, active hepatitis B or hepatitis C patients (HBsAg positive patients with HBV (hepatitis B virus) DNA ≥ 10\\^3 copies or ≥ 200 IU\u002FmL; HCV antibody test results are positive, and HCV (hepatitis C virus) RNA PCR test results are positive).\n7. Concomitant malignancies or previous malignancies\n8. Concurrent use of therapeutic warfarin is allowed. However, anticoagulants that do not have reversal agents available are prohibited except low molecular weight heparin and direct oral anticoagulants.\n9. Any toxicities from prior treatment that have not recovered to ≤ CTCAE Grade 1\n10. There were ≥ 3 lesions with punctate bleeding, any active bleeding, intratumoral bleeding, known bleeding tendencies, or treatment with antiplatelet\u002Fantithrombotic drugs.\n11. Gastrointestinal condition which could impair absorption of study medication;\n12. Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol;\n13. Cardiac exclusion criteria:\n\n1.History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 3 months prior to first dose of study drug; 2.Fridericia's corrected QT interval (QTcF) \\> 450 ms (for male) and \\> 470 ms (for female) on ECG conducted during screening; 3.Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death; 4.History or current evidence of serious uncontrolled ventricular arrhythmias; 5.Symptomatic congestive heart failure (Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system) within the previous 3 months; 6.Left ventricular ejection fraction (LVEF) \\\u003C 50%; 14. Any evidence of serious active infections requiring antibiotics; 15. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drug or their excipients; 16. Pregnant or breast-feeding female; 17. Contraception: 18. Other serious illness or medical conditions at the Investigator's discretion, that may influence study results 19. Previously received treatment with EZH2 or EZH1\u002F2 inhibitors. 20. Grade 3b FL or evidence of transformation to invasive lymphoma",{"count":174,"type":19},254,[22,23],"This is an open-label, multicenter, first-in-human phase I\u002FII study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.",[178,48,179,180],"FL Lymphoma","Peripheral T Cell Lymphoma","Advanced Solid Tumor",[182,183,184,185],"Phase I\u002FII","HH2853","PRC2","EZH 1\u002F2 inhibitor","2026-01-28",{"date":188,"type":74},"2026-01-30",{"date":190,"type":74},"2020-09-08",{"date":192,"type":19},"2028-12-31",{"name":194,"class":137},"Haihe Biopharma Co., Ltd.",25,{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":206,"phases":4,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":219},"100293424","an-observational-study-on-epithelioid-sarcoma-100293424","NCT03099681","An Observational Study on Epithelioid Sarcoma","Epithelioid Sarcoma. An Observational Study","EPISObs","Inclusion criteria\n\n1. Histological diagnosis of epithelioid sarcoma according to 2014 World Health Organization (WHO) classification, performed on biopsy or surgical specimen\n2. Signed informed consent\n3. Adequate patient compliance to treatment or follow up\n4. No age limit\n\nExclusion criteria\n\n1. Other malignancies within past 5 years, with exception of carcinoma in situ of the cervix and basocellular skin cancers treated with eradicating intent\n2. Impossibility to ensure adequate compliance",{"count":205,"type":19},100,"OBSERVATIONAL","Prospective Italian study aimed to provide a description of the population affected by Epithelioid Sarcoma (ES)",[48],"2025-11-17",{"date":211,"type":74},"2025-11-18",{"date":213,"type":74},"2017-08-22",{"date":215,"type":19},"2030-03-31",{"name":217,"class":218},"Italian Sarcoma Group","NETWORK",11,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":15,"minAge":145,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":20,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":120},"100537386","phase-2-masct-i-combined-with-doxorubicin-and-ifosfamide-for-first-line-treatment-of-advanced-soft-tissue-sarcoma-100537386","NCT06277154","MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma","A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. Age≥18 years and≤70 years;\n2. According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.\n3. No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.\n4. At least one measurable and assessable lesion defined by RECIST 1.1;\n5. ECOG performance status of 0-1;\n6. Estimated life expectancy≥6 months;\n7. Pulmonary function is basically normal;\n8. Subjects with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g\u002FL; b) Leukocyte≥3.5x10\\^9\u002FL; c) The absolute neutrophil count (ANC)\\>1.5x10\\^9\u002FL; d) Platelet≥100x10\\^9\u002FL; e) ALT, AST≤2.5 ULN (Upper Limit of Normal), ALT, AST≤5 ULN for liver metastases; f) ALP≤2.5 ULN; g) Serum total bilirubin≤1.5 ULN; Patients with Gilbert's syndromes (persistent or repeated hyperbilirubinemia \\[mainly unconjugated bilirubin\\], in the absence of evidence of hemolysis or liver disease), are allowed to enroll with investigator's agreement; h) Serum urea nitrogen or urea and creatinine≤2.5 ULN; i) Serum albumin≥35g\u002FL; j) PT, APTT, INR≤1.5 ULN (without anticoagulation treatment);\n9. Obtain the written informed consent of the patient\u002Flegal representative;\n10. Subjects with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was included.\n\nExclusion Criteria:\n\n1. Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization, or have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization.\n2. Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma\u002Fhemangiopericytoma, acinous soft tissue sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor, invasive fibroma, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, etc., which are not suitable for Doxorubicin+ Ifosfamide (AI) treatment.\n3. Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg\u002Fm2 doxorubicin.\n4. Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.\n5. Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg\u002Fday prednisone or its equivalent) and were still using them within 2 weeks before randomization.\n6. Use of immunomodulators and were still using them within 2 weeks before randomization.\n7. Allergic to sodium citrate or human albumin.\n8. Subjects with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.\n9. Have known active central nervous system (CNS) or meningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have returned to baseline at least 2 weeks before randomization, 2) no requirement for steroids at least 2 weeks before randomization or receiving low-dose of steroids (Not exceeding 10mg\u002Fday prednisone or its equivalent).\n10. Have any active autoimmune disease or history of autoimmune disease.\n11. Subjects with active tuberculosis.\n12. Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.\n13. Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT\u002FQTc interval at baseline (male\\>450ms, female \\>480ms); (4) LVEF≤50%; (5) heart failure of NYHA class 2 or higher; (6) poorly controlled hypertension (BP≥150\u002F95 mmHg, despite optimal medical treatment); (7) cardiomyopathy or severe arrhythmia and may have impact on the study based on investigator's judgement.\n14. Subjects with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;\n15. Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;\n16. Known history of organ transplantation or ready to receive an organ transplantation;\n17. Subjects who have undergone major surgery or traumatic injury within 4 weeks before randomization;\n18. Those who have a history of alcohol dependence, psychotropic substance abuse and cannot abstain or have mental disorders.\n19. Surgery for soft tissue sarcoma is planned during the study.\n20. Subjects have participated in another investigational trial within 4 weeks before randomization.\n21. Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.","70 Years",{"count":229,"type":19},148,[23],"This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.",[44,27,47,32,233,48,234,235,236,237,100],"Undifferentiated Pleomorphic Sarcoma","Malignant Peripheral Nerve Sheath Tumors","Fibrosarcoma","Pleomorphic Rhabdomyosarcoma","Endometrial Stromal Sarcoma","2025-07-20",{"date":240,"type":74},"2025-07-24",{"date":242,"type":74},"2024-02-21",{"date":244,"type":19},"2027-02",{"name":246,"class":137},"HRYZ Biotech Co."]