[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"City of Hope Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":607},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,181,0,25,[9,43,68,87,112,131,157,179,200,241,269,295,313,332,353,372,395,418,438,462,484,505,529,565,585],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100642952","individualized-aml-treatment-100642952",false,"NCT07613385","Individualized AML Treatment","Feasibility Study of Individualized Treatment Recommendations for Acute Myeloid Leukemia Based on High Throughput Screening and Genomics Data","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n* Age: ≥ 18 years\n* ECOG ≤ 3 (Appendix A)\n* Patients with histologically confirmed AML according to ICC or WHO criteria, and\n* Refractory\u002Frelapsed (R\u002FR) to prior treatment with one or more regimens if adverse risk or two or more regimens if favorable\u002Fintermediate risk (Appendix B)\n* Sufficient bone marrow and\u002For peripheral blood sample (archival or fresh) to run the high throughput screening (HTS; Estimate sufficient if circulating blast count of 5,000 or greater or cellular marrow with greater than or equal to 20% blasts.) Otherwise,\n* Sufficient cells flushed from bone marrow biopsy, if bone marrow is not aspirable, OR\n* Extramedullary disease, if it is possible to obtain a fluid or biopsy sample from that location\n* Expected survival is greater than 100 days.\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ Grade 1 to prior anti-cancer therapy\n\nExclusion Criteria:\n\n* Treatment with any chemotherapeutic agent necessary to control AML burden is permitted between day -18 and -1.\n* Must not have received or planning to receive live vaccine while being on study\n* Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)\n* Active central nervous system (CNS) disease (OK if treated and responding)\n* Active graft vs host disease (GVHD)\n* Unstable cardiac disease as defined by one of the following:\n* Cardiac events such as myocardial infarction (MI) within the past 6 months\n* Uncontrolled atrial fibrillation or hypertension\n* Clinically significant uncontrolled illness\n* Uncontrolled active infection\n* Females only: Pregnant or breastfeeding\n* Any other condition or active malignancy that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).","ALL","18 Years",{"count":20,"type":21},18,"ESTIMATED","OBSERVATIONAL","Every patient responds differently to their cancer treatment, and some treatments work better for some patients more than others. For patients with relapsed, refractory ( R\u002FR) AML, there may be fewer approved treatment options remaining. In this research study, the investigators are testing whether high throughput drug screening (HTS) in combination with robust molecular testing by HopeSeq (includes DNA sequencing for \\>500 genes and 160 gene rearrangements and RNAseq for \\>5,000 genes) can help doctors determine which treatment might work best for each individual patient. HTS tests how the patient's own AML cells respond to different treatment options including individual drugs and triple drug regimens and recommends for the best treatment options for an individual patient. Participants will provide extra bone marrow and\u002For blood at the time of routine procedure, and these extra sample(s) will be tested using the Cancer Drug Sensitivity Test ( CDST) HTS, CLIA approved in Washington state since 2014. A committee (the Functional Molecular Tumor Board) will review the HopeSeq and HTS results, past treatments, and clinical description, and give a recommendation for the best AML treatment options for each individual patient. The patient's doctor will get a copy of the recommendation and discuss treatment options with the patient. The patient and their doctor will decide on the best treatment plan for the patient, one which will be approved by insurance. Patients will not be treated with any drugs as part of this study. Then at 6 and 12 months, there will be retrospective review of medical records to determine how will the testing predicted the response, drug sensitivity or resistance, and overall and disease-free survival will be monitored.",[25],"Relapsed\u002FRefractory Acute Myeloid Leukemia (AML)",[27,28,29],"Feasibility study","Acute myeloid leukemia","Individualized treatment","RECRUITING","2026-08-19",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2026-01-28",{"date":38,"type":21},"2028-06-01",{"name":40,"class":41},"City of Hope Medical Center","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":42},"100639337","scheduled-meditation-for-improving-postoperative-outcomes-in-patients-undergoing-pancreatectomy-100639337","NCT07608458","Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy","Scheduled Meditation for Perioperative Optimization: A Randomized Controlled Trial on Postoperative Outcomes, Pain, Anxiety, Insomnia, Stress, and Mobility in Pancreatectomy Patients","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Willing to install required apps on personal smartphone\n* Willing to wear a Garmin wearable device throughout the study\n* Age: ≥ 18 years\n* Ability to read and understand English for questionnaires\n* Owns a smartphone\n* Comfortable with routine smartphone use\n* Scheduled to undergo pancreatectomy\n\nExclusion Criteria:\n\n* Participants with prior formal training in meditation or mindfulness (e.g., completion of structured courses, workshops, or certification programs)\n* Participants who currently engage in a structured meditation or mindfulness practice, including regular use of mobile applications (e.g., Headspace, Calm, or similar platforms) or other formalized routines",{"count":51,"type":21},70,"INTERVENTIONAL",[54],"NA","This clinical trial tests the feasibility and how well a scheduled meditation intervention works to improve postoperative outcomes such as pain, anxiety, insomnia, stress and mobility for patients undergoing pancreatectomy. Many patients undergoing pancreatectomy surgery report clinically important fatigue, pain, and\u002For reduction in quality of life. Meditation is a behavioral intervention that has been studied in a variety of medical and surgical settings, where it has been associated with reductions in pain, anxiety, blood pressure, and lack of sleep, and in some cases with decreased pain and shorter length of stay. The meditation intervention using Headspace is an easily accessible and interactive way to complete scheduled meditation. This may improve postoperative outcomes for patients undergoing pancreatectomy.",[57,58,59],"Hepatocellular Carcinoma","Pancreas Cancer","Biliary Tract Neoplasms","NOT_YET_RECRUITING",{"date":62,"type":34},"2026-08-20",{"date":64,"type":21},"2026-10-01",{"date":66,"type":21},"2026-11-25",{"name":40,"class":41},{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":52,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":84,"leadSponsor":86,"locationsCount":42},"100614101","phase-2-pembrolizumab-in-combination-with-chemotherapy-for-the-treatment-of-frail-hodgkin-lymphoma-patients-ineligible-for-standard-treatment-100614101","NCT07275216","Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment","Phase 2 Study of Pembrolizumab With Chemotherapy in Frail Patients With Newly Diagnosed Classical Hodgkin Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Meets at least one of the following criteria indicating unsuitability for conventional anthracycline-based frontline chemotherapy, as determined by the investigator:\n\n  * Age ≥ 75 years\n  * Eastern Cooperative Oncology Group (ECOG) 2-4\n  * Left ventricular ejection fraction (LVEF) \\\u003C 50%\n  * Creatinine clearance \\\u003C 60 mL\u002Fmin, using Cockcroft-Gault formula or equivalent\n  * Pulmonary function impairment: forced expiratory volume in 1 second (FEV1) \\\u003C 50% and\u002For diffusion capacity of the lung for carbon monoxide (DLCO) \\\u003C 50%\n* ECOG ≤ 2\n* Age ≥ 18 years\n* Histologically confirmed new diagnosis of classical Hodgkin lymphoma (excluding nodular lymphocyte predominant Hodgkin lymphoma) according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution\n* No prior systemic treatment for classical Hodgkin lymphoma with the following exceptions: a course of systemic corticosteroids for palliation of symptoms related to the classical Hodgkin lymphoma is allowed but must be stopped by cycle 1 day 1 (C1D1) as well as prior treatment with P-G as part of this clinical trial for patients will receive P-BV-D\n* Measurable disease (at least one non-bone fludeoxyglucose F-18 \\[FDG\\]-avid lesion ≥ 1.5 cm in long axis)\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Platelets ≥ 50,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 2 × upper limit of normal (ULN) or direct bilirubin ≤ 2 × ULN for patients with Gilbert's disease\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN\n* AST and ALT ≤ 3 x ULN unless there is liver involvement by lymphoma in which case AST and ALT \\\u003C 5 x ULN\n* For patients for whom P-BV-D therapy is planned, creatinine clearance of ≥ 30 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN\n\n  * If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n\n  * If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants\n* Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HBV or HCV, nucleic acid quantitation must be performed. Viral load must be undetectable. Patients with occult or prior HBV infection (defined as negative hepatitis B virus surface antigen \\[HBsAg\\] and positive hepatitis B core antibody \\[HBcAb\\]) may be included if HBV DNA is undetectable, if they are willing to undergo DNA testing on day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* A male participant must agree to use a contraception during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP) OR\n  * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least (X days\u002Fweeks \\[corresponding to time needed to eliminate any study treatment(s)\\] \\[pembrolizumab and\u002For any active comparator\u002Fcombination\\] plus 30 days \\[a menstruation cycle\\] for study treatments with risk of genotoxicity) after the last dose of study treatment\n* TO PROCEED WITH SALVAGE TREATMENT: ECOG ≤ 2\n* TO PROCEED WITH SALVAGE TREATMENT: Resolution of treatment-related adverse events (AEs) to baseline or grade 1, whichever is higher\n* TO PROCEED WITH SALVAGE TREATMENT: Measurable disease (at least one non-bony FDG-avid lesion ≥ 1.5 cm in long axis)\n* TO PROCEED WITH SALVAGE TREATMENT: Peripheral neuropathy ≤ grade 2\n* TO PROCEED WITH SALVAGE TREATMENT: ANC ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factors are permitted\n* TO PROCEED WITH SALVAGE TREATMENT: Platelets ≥ 50,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are permitted\n* TO PROCEED WITH SALVAGE TREATMENT: Hemoglobin ≥ 8 g\u002FdL (no transfusion allowed within 3 days prior to screening)\n* TO PROCEED WITH SALVAGE TREATMENT: Total bilirubin ≤ 2 x ULN or direct bilirubin ≤ 2 x ULN for patients with Gilbert's disease\n* TO PROCEED WITH SALVAGE TREATMENT: AST ≤ 3 x ULN, or less then 5 x ULN for patients with liver involvement by lymphoma\n* TO PROCEED WITH SALVAGE TREATMENT: ALT ≤ 3 x ULN, or less then 5 x ULN for patients with liver involvement by lymphoma\n* TO PROCEED WITH SALVAGE TREATMENT: Creatinine clearance of ≥ 30 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula\n\nExclusion Criteria:\n\n* Concomitant investigational therapy\n* Live vaccine within 30 days prior to day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacille Calmette Guerin \\[BCG\\], oral polio vaccine, and oral typhoid)\n* Grade ≥ 2 peripheral neuropathy\n* Requirement for hemodialysis or peritoneal dialysis. Estimated glomerular filtration rate (EGFR) \\> 30 for pembrolizumab + BV + dacarbazine\n* Known active central nervous system (CNS) involvement by lymphoma including parenchymal and\u002For lymphomatous meningitis\n* History of prior ≥ grade 3 hypersensitivity to either brentuximab vedotin or pembrolizumab\n* Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)\n* History of another primary malignancy that has been in remission for fewer than 3 years, with the following exceptions:\n\n  * Non-melanoma skin cancer treated with curative intent\n  * In situ cervical cancer\n  * If the malignancy is expected to not require any systemic treatment for at least 2 years (this exception should be discussed with the study PI)\n* Condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Exceptions are:\n\n  * Inhaled or topical steroids and\n  * Adrenal replacement doses \\> 10 mg daily prednisone equivalents in the absence of active autoimmune disease\n  * Up to 7 days of 20 mg daily prednisone equivalent after C1D1 for management of lymphoma-related symptoms\n* History of progressive multifocal leukoencephalopathy (PML)\n* Active pneumonitis or interstitial lung disease\n* Prior solid organ or allogeneic stem cell transplantation\n* History of known or suspected hemophagocytic lymphohistiocytosis (HLH)\n* Active, known or suspected autoimmune disease. The following are exceptions:\n\n  * Vitiligo\n  * Psoriasis not requiring systemic treatment\n  * Hemolytic anemia associated with the lymphoma\n  * Type I diabetes mellitus, if adequately controlled with therapy\n  * Thyroid disease, if adequately controlled with therapy\n  * Conditions not expected to recur in the absence of an external trigger (such exceptions should be discussed with the study PI)\n* Active history of:\n\n  * Hepatitis B (HBV) or C (HCV) infection. Patients with past HBV infection (defined as negative HBsAg and positive hepatitis B core antibody \\[HBcAb\\]) are eligible if HBV DNA is undetectable. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV RNA\n* HIV positive\n* History of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association class III-IV within 6 months prior to day 1 of protocol therapy\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":76,"type":21},23,[78],"PHASE2","This phase II trial tests how well pembrolizumab in addition to chemotherapy (gemcitabine, brentuximab vedotin, and dacarbazine) works in treating frail patients with newly diagnosed Hodgkin lymphoma who aren't candidates for standard anthracycline-based treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. Dacarbazine is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells and slow down or stop cancer growth. Pembrolizumab in combination chemotherapy may be a safe and effective alternative treatment option for frail patients with Hodgkin lymphoma who can't receive standard anthracycline-based treatment.",[81],"Classic Hodgkin Lymphoma",{"date":62,"type":34},{"date":64,"type":21},{"date":85,"type":21},"2029-10-20",{"name":40,"class":41},{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":52,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100613804","phase-3-pressurized-intraperitoneal-aerosolized-chemotherapy-with-mitomycin-for-the-treatment-of-unresectable-appendix-or-colorectal-cancer-with-peritoneal-metastases-the-impact-trial-100613804","NCT07271355","Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial","Investigation of Mitomycin C PIPAC - FOLFIRI Combination for Unresectable Appendiceal or Colorectal Peritoneal Metastases Treatment (IMPACT): A Multicenter, Randomized, Open-Label, Phase 3 Trial","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically or cytologically confirmed appendiceal or colorectal cancer peritoneal metastases\n* No extraperitoneal metastases except lung ≤ 5 lesions with largest ≤ 1cm as identified on CT imaging or MRI. CT scan or MRI to assess measurable disease must have been completed within 28 days prior to registration\n* Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy (does not have to be measurable by RECIST (v1.1)\n* Completed at least 4 months (8 cycles) of first-line standard-of-care oxaliplatin-based systemic therapy without progression of disease. Or completed less than 4 months of oxaliplatin based therapy due to intolerance and without progressive disease. Or progressed on first-line standard-of-care oxaliplatin-based systemic therapy. Permissible first-line systemic therapies include leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (XELOX) or fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFOXIRI). Receipt of anti-EGFR, anti-VEGF, or anti-BRAF therapy in the first-line is acceptable. Mismatch repair-deficient patients are permissible if they have progressed on first-line immunotherapy\n* Not a candidate for cytoreductive surgery as determined by site investigator\n* Fully recovered from the acute toxic effects of prior anti-cancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or lower except alopecia, hearing loss, neuropathy, or non-clinically significant laboratory abnormalities\n* Complete medical history and physical exam (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Platelets ≥ 100,000\u002FmcL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Hemoglobin ≥ 8 g\u002FdL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Serum albumin ≥ 2.8 g\u002FdL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, then direct bilirubin \\\u003C 1.5 mg\u002FdL) (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) ≤ 5 x ULN (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) ≤ 5 x ULN (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Calculated creatinine clearance of ≥ 45 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula (To be performed within 28 days prior to Day 1 of protocol therapy)\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (To be performed within 28 days prior to Day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control (e.g. licensed hormonal\u002Fbarrier methods or surgery intended to prevent pregnancy \\[or with a side effect of pregnancy prevention\\]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* CROSS-OVER ARM INCLUSION: Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* CROSS-OVER ARM INCLUSION: Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with Study PI approval\n* CROSS-OVER ARM INCLUSION: Age: ≥ 18 years\n* CROSS-OVER ARM INCLUSION: ECOG performance status of 0 or 1\n* CROSS-OVER ARM INCLUSION: No extraperitoneal metastases except lung ≤ 5 lesions with largest ≤ 1cm as identified on CT imaging or MRI. CT scan or MRI to assess measurable disease must have been completed within 28 days prior to registration\n* CROSS-OVER ARM INCLUSION: Progression on Control Arm of the Study as determined by RECIST v1.1. Non-radiographic progression will need to be assessed on a case-by-case basis by central review\n* CROSS-OVER ARM INCLUSION: Fully recovered from the acute toxic effects of prior anti-cancer therapy to CTCAE grade 1 or lower except alopecia, hearing loss, neuropathy, or non-clinically significant laboratory abnormalities\n* CROSS-OVER ARM INCLUSION: Complete medical history and physical exam (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: ANC ≥ 1,500\u002FmcL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Platelets ≥ 100,000\u002FmcL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Hemoglobin ≥ 8 g\u002FdL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Serum albumin ≥ 2.8 g\u002FdL (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Total bilirubin ≤ 1.5 X ULN (unless has Gilbert's disease, then direct bilirubin \\\u003C1.5 mg\u002FdL) (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: AST ≤ 5 x ULN (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: ALT ≤ 5 x ULN (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Calculated creatinine clearance of ≥ 45 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula (To be performed within 28 days prior to Day 1 of protocol therapy)\n* CROSS-OVER ARM INCLUSION: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (To be performed within 28 days prior to Day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* CROSS-OVER ARM INCLUSION: Agreement by females and males of childbearing potential to use an effective method of birth control (e.g. licensed hormonal\u002Fbarrier methods or surgery intended to prevent pregnancy \\[or with a side effect of pregnancy prevention\\]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* More than 8 cycles of first line irinotecan therapy\n* Progression on irinotecan\n* Receipt of any second-line systemic chemotherapy (Note: Sequential administration of FOLFOX followed by FOLFIRI is considered second line therapy. However, FOLFOXIRI followed by FOLFIRI is considered first line as long as no more than 8 cycles of irinotecan are given)\n* Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable\n* Strong CYP3A4 inducers\u002Finhibitors within 14 days prior to Day 1 of protocol therapy\n* Prior peritoneal-directed chemotherapy (Prior cytoreductive surgery is permitted)\n* Participation in another clinical study with an investigational product administered in the last 2 months\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n* Low-grade appendiceal mucinous neoplasm or low-grade appendiceal mucinous adenocarcinoma\n* Extraperitoneal metastases (except lung ≤ 5 lesions with largest being ≤ 1cm)\n* Any history of bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy, or need for total parenteral nutrition. Even if the bowel obstruction resolved with conservative measures, the patient would be excluded. The exception is if the bowel obstruction was surgically addressed with ostomy, resection or bypass. This exception should be documented\n* Fused mesenteric disease-causing mesenteric shortening and bowel sequestration (\"cauliflowering\")\n* Bulky mesenteric disease where chemotherapy is unlikely to penetrate the tumor\n* Contraindication to laparoscopy\n* Rapid weight loss (\\> 10% in \\\u003C 3 months)\n* Ascites (\\> 2L drained per month)\n* Adhesions involving \\> 50% of abdominal cavity on diagnostic laparoscopy\n* Life expectancy \\\u003C 6 months\n* Treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 Cycle 1 of treatment\n\n  * Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved\n* Any prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years\n* History of allergic or hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to study agents (platinum-based compounds, etc.)\n* History of allogeneic organ transplantation or other active primary immunodeficiency\n* Active and uncontrolled infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), or human immunodeficiency virus (positive HIV 1\u002F2 antibodies)\n* Clinically significant uncontrolled illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase the risk of incurring AEs, or compromise the ability of the patient to give written informed consent\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)\n* CROSS-OVER ARM EXCLUSION: Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable\n* CROSS-OVER ARM EXCLUSION: Strong CYP3A4 inducers\u002Finhibitors within 14 days prior to Day 1 of protocol therapy\n* CROSS-OVER ARM EXCLUSION: Participation in another clinical study with an investigational product administered in the last 2 months other than the current study\n* CROSS-OVER ARM EXCLUSION: Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n* CROSS-OVER ARM EXCLUSION: Extraperitoneal metastases (except lung ≤ 5 lesions with largest being ≤ 1cm)\n* CROSS-OVER ARM EXCLUSION: Any history of bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy, or need for total parenteral nutrition. Even if the bowel obstruction resolved with conservative measures, the patient would be excluded. The exception is if the bowel obstruction was surgically addressed with ostomy, resection or bypass. This exception should be documented\n* CROSS-OVER ARM EXCLUSION: Fused or bulky mesenteric disease-causing mesenteric shortening and bowel sequestration\n* CROSS-OVER ARM EXCLUSION: Contraindication to laparoscopy\n* CROSS-OVER ARM EXCLUSION: Rapid weight loss (\\> 10% in \\\u003C 3 months)\n* CROSS-OVER ARM EXCLUSION: Ascites (\\> 2L drained per month)\n* CROSS-OVER ARM EXCLUSION: Adhesions involving \\> 50% of abdominal cavity on diagnostic laparoscopy\n* CROSS-OVER ARM EXCLUSION: Life expectancy \\\u003C 6 months\n* CROSS-OVER ARM EXCLUSION: Treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 Cycle 1 of treatment\n\n  * Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved",{"count":95,"type":21},129,[97],"PHASE3","This phase III trial studies how well pressurized intraperitoneal aerosolized chemotherapy (PIPAC) with mitomycin works versus (vs) standard chemotherapy (leucovorin calcium, fluorouracil, and irinotecan hydrochloride \\[FOLFIRI regimen\\] plus bevacizumab) in treating patients with appendix or colorectal cancer that cannot be removed by surgery (unresectable) and has spread from where it first started (primary site) to the abdominal cavity (peritoneal metastases). PIPAC is a new therapeutic approach that is minimally invasive, does not require surgery (laparotomy), and can be frequently repeated. Chemotherapy is delivered as a pressurized mist directly inside the abdominal cavity (peritoneum) during a minimally invasive surgery called a laparoscopy. The pressure helps the chemotherapy absorb into the cancer tissue and spread more evenly. Mitomycin is an antibiotic used as a chemotherapy drug. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their deoxyribonucleic acid (DNA). Standard chemotherapy drugs, such as those in the FOLFIRI regimen, are given via infusion into a vein (intravenously), and 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. Another standard intravenous drug, bevacizumab, is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving mitomycin via PIPAC in combination with the standard FOLFIRI regimen, with or without bevacizumab, may work better than standard FOLFIRI plus bevacizumab alone in treating patients with unresectable appendix or colorectal cancer with peritoneal metastases.",[100,101,102,103,104,105],"Metastatic Appendix Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Malignant Neoplasm in the Peritoneum","Stage IV Appendix Carcinoma AJCC v8","Stage IVC Colorectal Cancer AJCC v8","Unresectable Colorectal Carcinoma",{"date":33,"type":34},{"date":64,"type":21},{"date":109,"type":21},"2031-02-28",{"name":40,"class":41},5,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":52,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":128,"leadSponsor":130,"locationsCount":42},"100610305","geriatric-assessment-and-management-for-older-adults-undergoing-chemotherapy-and-radiation-therapy-for-head-and-neck-cancer-and-their-family-caregivers-100610305","NCT07225855","Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer and Their Family Caregivers","Geriatric Assessment and Management for Older Adults Undergoing Radiation Therapy for Head and Neck Cancer and Their Family Caregivers","Inclusion Criteria:\n\n* PATIENT: Documented written informed consent of the participant\n* PATIENT: Diagnosis of non-metastatic head and neck cancer\n* PATIENT: Age: ≥ 60 years\n* PATIENT: Patient must be scheduled to undergo curative-intent, definitive radiation with or without concurrent chemotherapy or postoperative radiation with or without concurrent chemotherapy\n* PATIENT: Patients must have at least one geriatric assessment as assessed by the modified Geriatric 8 (G8) tool\n* PATIENT: Family caregivers (FCGs) are highly encouraged to participate but this is not required. Patients without FCGs will be eligible to participate in the study. FCGs will be randomized to the same arm as their corresponding patients\n* PATIENT: Ability to read and understand English\n* CAREGIVER: A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care\n* CAREGIVER: Ability to read and understand English\n* CAREGIVER: Age 18 years or older",true,{"count":121,"type":21},36,[54],"This clinical trial compares the effect of geriatric assessment (GA)-based management of supportive care to usual care in treating older patients undergoing chemotherapy and radiation therapy for head and neck cancer and their family caregivers (FCG). At least one quarter of head and neck cancers patients are diagnosed at age 70 or older. Treatment for head and neck cancers usually include surgery, chemotherapy, and radiation. Older adults are often at higher risk for functional problems, and may experience more side effects. In addition, there may be a lack of support mechanisms in place to address the needs of these older patients. Cancer not only affects the patients but the entire family, especially the family member who is the caregiver. Currently, all patients over 65 receive the same standard of care based on national guidelines, which include supportive care referrals. However, data suggests, that many patients may need more frequent and structured support. The Practical Geriatric Assessment (PGA) is a complete examination including evaluation of the physical and mental function as well as the emotional state of the older patient. PGA-based supportive care interventions may be safe, tolerable, and\u002For effective in managing treatment-related side effects and improving quality of life compared to usual care in older patients undergoing chemotherapy and radiation therapy for head and neck cancer and their FCG.",[125],"Localized Head and Neck Carcinoma",{"date":33,"type":34},{"date":64,"type":21},{"date":129,"type":21},"2027-11-24",{"name":40,"class":41},{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":52,"phases":142,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100597675","phase-1-a-randomized-phase-12-trial-of-low-dose-anti-thymocyte-globulin-atg-with-subsequent-adalimumab-or-verapamil-in-new-onset-type-1-diabetes-100597675","NCT07061574","A Randomized Phase 1\u002F2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes","WAVE T1D","Key Inclusion Criteria:\n\n1. Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit.\n2. At least one positive T1D auto-antibody.\n\n   * If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required.\n   * Insulin auto-antibodies are only considered if exogenous insulin use is \\\u003C10 days when blood is drawn.\n3. Must have stimulated C-peptide levels ≥0.2 pmol\u002FmL measured during MMTT conducted prior to randomization.\n4. Age 9 to \\\u003C21 years at the time of randomization.\n5. Body weight \\>30kg.\n6. BMI \\\u003C95th percentile for age and gender.\n7. Willing to comply with intensive diabetes management.\n8. Female participants with childbearing potential are not currently pregnant, are willing to avoid pregnancy and breastfeeding, and to undergo pregnancy testing prior to MMTTs for the duration of the study.\n9. Women of childbearing potential (WOCBP) must use an acceptable form of birth control. Acceptable forms include oral\u002Finjection contraceptives, transdermal contraceptives, diaphragm, intrauterine devices, condoms with spermicide, documented surgical sterilization of either the participant or their partner or abstinence.\n10. Male participants with potential to father children must be willing to use abstinence or adequate contraceptive methods for the duration of the study.\n11. Males must agree to be sexually abstinent or use a condom and agree not to donate sperm for the treatment period and for a minimum of 1 spermatogenesis cycle (90 days after last dose of study drug) after last treatment.\n12. Willing to provide informed consent and child assent as applicable.\n13. Sufficient cognitive ability, per investigator judgment, to provide informed consent for study participation on an IRB approved consent form.\n14. Able to read and understand English or Spanish (both participant and legally authorized representative, if applicable).\n15. Must be fully vaccinated for age.\n16. Must have been vaccinated for flu (if currently in flu season).\n17. Must be willing to not receive live vaccines throughout the treatment period.\n18. Must be willing to not use any non-insulin glucose-lowering agents such as GLP-1 agonists (including for weight loss indication), symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas) for the duration of study treatment. Participants are required to go off these drugs at least 30 days prior to screening.\n\nKey Exclusion Criteria:\n\n1. Prior treatment with ATG or known allergy to ATG or rabbit-derived products.\n2. Local lab draw at screening:\n3. Immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (\\\u003C3,000 leukocytes \u002FμL), neutropenia (\\\u003C1,500 neutrophils\u002FμL), lymphopenia (\\\u003C800 lymphocytes\u002FμL).\n4. Thrombocytopenia (\\\u003C100,000 platelets\u002FμL) or anemia (hemoglobin \\\u003C 10g\u002FdL).\n5. Leukocytosis (\\>14,000\u002FmL)\n6. Infections:\n7. Ongoing infection or had recently had a major infection requiring hospitalization or intravenous antibiotics.within 30 days prior to randomization.\n8. Have active signs or symptoms of acute infection at the time of randomization.\n9. Have evidence of prior or current tuberculosis infection as assessed interferon gamma release assay (QuantiFERON), or a positive test for latent tuberculosis.\n10. Have evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.\n11. History of serious bacterial, viral, fungal, or other opportunistic infections.\n12. Have active signs or symptoms of CMV or EBV compatible illness lasting more than 7 days within 30 days of randomization.\n13. Have positive CMV and\u002For EBV PCR test within 30 days prior to randomization.\n14. Have positive COVID-19 self-antigen test within 3 days of randomization.\n15. History of underlying cardiac disease (ex. left ventricular dysfunction, hypertrophic cardiomyopathy), certain arrhythmias (e.g. AV block, accessory pathway such as Wolff- Parkinson-White or Lown-Ganong-Levine syndromes) or abnormal ECG (unless cleared by cardiology).\n16. Blood pressure (either systolic or diastolic) \\\u003C5th percentile for age, gender, and height on two out of three measurements.\n17. Pulse \\\u003C2nd percentile for age and gender on two out of three measurements.\n18. History of vasovagal syncopal episodes related to hypotension.\n19. History of malignancies other than of skin.\n20. Use of medications likely to interfere with study results:\n21. Any immunomodulators, including systemic steroids or participation in prior research study in which a potential participant received an immunomodulatory agent (may participate if received placebo only).\n22. Current or previous use of Teplizumab.\n23. Ongoing use of medications known to influence glycemia or glucose tolerance. Only topical steroids are allowed.\n24. Need to use of any of the following medications during the study: beta blocker, seizure medication (carbamazepine, phenobarbital, phenytoin), other antihypertensive medications, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine.\n25. Receipt of live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guerin, and smallpox) within the 90 days before randomization.\n26. Any known hypersensitivity reaction to any of the study medications or their components.\n27. Unable to swallow pills (tested with an inert imitation tablet in clinic at screening).\n28. History of significant allergy (e.g., anaphylaxis) to milk or soy proteins in the Boost drink required for study MMTT testing.\n29. Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor).\n30. Established history of allergy or severe reaction to adhesive or tape that must be used in the study.\n31. Participation in another treatment research study that involves diabetes care or immune modulation, unless the participant is able to confirm that they were in the placebo arm.\n32. Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:\n33. Alcohol or drug abuse\n34. Untreated or inadequately treated mental illness\n35. Liver disease or LFTs \\>2x ULN.\n36. Renal disease or creatinine greater than 1.5x ULN.\n37. Other autoimmune diseases except for stable and treated hypothyroidism\n38. Graves' disease, or celiac disease (e.g., symptom-free on a gluten free diet).\n39. Nervous system disorder including but not limited to Guillain-Barre\n40. Syndrome, multiple sclerosis, progressive multifocal leukoencephalopathy.\n\n41 .History of multiple abdominal surgeries and\u002For at increased risk for bowel obstruction.\n\n42\\. Any clinical or laboratory conditions that the investigator feels would interfere with the study or participant safety (e.g., increased risk to pre-existing disease).\n\nAny lab abnormality believed to be transient may be repeated at the discretion of the site PI. If repeat value does not preclude participation, and potential participant would otherwise qualify for the study, then may proceed with enrollment per investigator discretion.\n\n\\-","9 Years","20 Years",{"count":141,"type":21},120,[143,78],"PHASE1","This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \\\u003C21 with recent-onset stage 3 T1D.",[146,147],"Type 1 Diabetes","New Onset",[149],"ATG, Verapamil, Adalimumab",{"date":33,"type":34},{"date":152,"type":34},"2026-03-10",{"date":154,"type":21},"2031-04-15",{"name":40,"class":41},11,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":164,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":52,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":42},"100501139","phase-1-psca-targeting-car-t-cells-plus-or-minus-radiation-for-the-treatment-of-patients-with-psca-metastatic-castration-resistant-prostate-cancer-100501139","NCT05805371","PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer","A Phase 1b Study Evaluating Combinations With PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative (brown)\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n\n    * Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated main consent is processed. However, the research participant is allowed to proceed with lymphodepletion and CAR T cell infusion only after the translated main consent form is signed\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky Performance Status (KPS) \\>= 70%\n* Documented castration resistant prostate cancer (mCRPC) (Note: castration will be defined by a testosterone \\\u003C 50 ng\u002FdL achieved by orchiectomy or luteinizing hormone-releasing hormone \\[LHRH\\] agonist\u002Fantagonist therapy)\n\n  * Documented PSCA+ tumor expression as evaluated by the COH Pathology Clinical Trials Specimen Qualification Laboratory (CTSQL)\n\n    * Fresh or archival biopsy samples may be tested for PSCA expression during screening for eligibility purposes. The results from soft tissue biopsies will be used to confirm eligibility for participants who have a soft-tissue lesion biopsy obtained, but bone biopsy staining results will not impact eligibility since immunohistochemistry (IHC) staining for PSCA has not been optimized in bone specimens. Subjects who undergo bone biopsy on study will be qualified based on the archival tissue result\n  * Progression of disease manifest by one of the following means during treatment with at least one advanced androgen targeted therapy (e.g., abiraterone or enzalutamide):\n\n    * Rising prostate specific antigen (PSA) documented on 2 occasions at least 7 days apart, with absolute increase \\> 2 ng\u002FdL despite testosterone \\\u003C 50 OR\n    * Radiographic evidence of new metastatic foci on CT or bone scan, or soft tissue progression by Response Evaluation Criteria in Solid Tumors (RECIST)\n  * For treatment plan 2, subjects must have at least one and up to 3 metastatic lesions which have not previously been radiated and which is safe for treatment with radiation 16 gray (Gy) in 2 fractions\n* Fully recovered from the acute toxic effects (except alopecia) to =\\\u003C grade 1 to prior anti-cancer therapy\n* If there has been prior chemotherapy, at least 2 weeks must have elapsed prior to leukapheresis\n* Prior radiotherapy is allowed provided it was not administered to the only evaluable site of disease and was completed \\> 14 days prior to leukapheresis\n* No known contraindications to leukapheresis, steroids or tocilizumab\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3 (within 42 days prior to enrollment)\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment\n* Platelets \\>= 100,000\u002Fmm\\^3 (within 42 days prior to enrollment) NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n* Total serum bilirubin =\\\u003C 2.0 mg\u002FdL (within 42 days prior to enrollment)\n\n  * Patients with Gilbert syndrome may be included if their total bilirubin is =\\\u003C 3.0 x upper limit of normal (ULN) and direct bilirubin =\\\u003C 1.5 x ULN\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (within 42 days prior to enrollment)\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (within 42 days prior to enrollment)\n* Creatinine clearance of \\>= 50 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 42 days prior to enrollment)\n* Corrected QT interval (QTc) =\\\u003C 480 ms\n\n  * Note: to be performed within 28 days prior to day 1 of protocol therapy\n* Cardiac function (12 lead- electrocardiogram \\[ECG\\]) without acute abnormalities requiring investigation or intervention (within 42 days prior to enrollment)\n* Seronegative for human immunodeficiency virus (HIV) antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \\[RPR\\])\n\n  * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed OR\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n  * Note infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Agreement by males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized\n\nExclusion Criteria:\n\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone =\\\u003C 7.5 mg \u002Fday, or hydrocortisone =\\\u003C 20 mg \u002Fday) is allowed\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening\n* Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \\>= 3 years\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","MALE",{"count":166,"type":21},21,[143],"This phase Ib trial tests the safety, side effects, and best dose of autologous anti-prostate stem cell antigen (PSCA)-chimeric antigen receptor (CAR)-4-1BB\u002FTCRzeta-CD19t-expressing T-lymphocytes (PSCA-CAR T cells), plus or minus radiation, in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Castration-resistant prostate cancer continues to grow and spread despite the surgical removal of the testes or medical intervention to block androgen production. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving PSCA-targeting CAR T-cells, with or without radiation, may kill more tumor cells in men with castration-resistant prostate cancer.",[170,171,172],"Castration-Resistant Prostate Carcinoma","Metastatic Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8",{"date":33,"type":34},{"date":175,"type":34},"2024-10-09",{"date":177,"type":21},"2028-11-11",{"name":40,"class":41},{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":52,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":42},"100459489","phase-1-8-chloroadenosine-in-combination-with-venetoclax-for-the-treatment-of-patients-with-relapsedrefractory-acute-myeloid-leukemia-100459489","NCT05263284","8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase 1 Trial of 8-Chloro-Adenosine in Combination With Venetoclax in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Age: \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2.\n* Life expectancy \\> 3 months.\n* Patients with histologically confirmed acute myeloid leukemia (AML), according to World Health Organization (WHO) criteria, with relapsed\u002Frefractory disease.\n* Patients must have any one of the following treatment history criteria:\n\n  * Relapsed AML\n\n    * Failed at least 1 line of salvage therapy or\n    * Untreated relapse and are not candidates for allogeneic hematopoietic stem cell transplantation (alloHCT)\n  * De novo AML\n\n    * have not achieved complete response (CR) after 2 lines of therapy or\n    * refractory to frontline therapy and not eligible for alloHCT\n  * AML evolving from myelodysplastic syndrome (MDS) or myeloproliferative disorder who have failed hypomethylating agents (HMA) or induction chemotherapy\n  * Patients who have relapsed after allo-HCT are eligible if they are at least 3 months after HCT, do not have active graft versus host disease (GVHD) and are off immunosuppression except for maintenance dose of steroids (prednisone 10 mg\u002Fday or less).\n* Male subjects must agree to not donate sperm while taking protocol therapy through at least 90 days after the last dose.\n* White blood cell (WBC) =\\\u003C 25 x 10\\^9\u002FL prior to initiation of venetoclax. Cytoreduction with hydroxyurea prior to treatment and\u002For during cycle 1 may be required.\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease).\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN.\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN.\n* Creatinine clearance of \\>= 50 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula.\n* QTc =\\\u003C 480 ms.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months (females) and 3 months (males) after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* Current or planned use of other investigational agents, antineoplastic, biological, chemotherapy, or radiation therapy during the study treatment period, or within 2 weeks prior to day 1 of protocol therapy, with the following exception:\n\n  * Hydroxyurea which may be continued through cycle 1.\n* Expected to undergo HCT within 120 days of enrollment.\n* Current or planned use of agents that prolong or suspected to prolong QTc.\n* Received strong or moderate CYP3A inducers or St. John's Wort within 7 days prior to day 1 of protocol therapy.\n* Received strong or moderate CYP3A inhibitors, or consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to day 1 of protocol therapy.\n* P-glycoprotein (P-gp) inhibitors within 7 days prior to day 1 of protocol therapy.\n* Narrow therapeutic index P-gp substrates within 7 days prior to day 1 of protocol therapy.\n* Acute promyelocytic leukemia.\n* Active central nervous system (CNS) leukemia.\n* Active fungal infection or bacterial sepsis.\n* Class III\u002FIV cardiovascular disability according to the New York Heart Association classification.\n* Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment. Subjects with controlled, asymptomatic atrial fibrillation can enroll.\n* History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment.\n* History of unexplained syncope, significant histories of CAD (requiring revascularization by percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]), cardiomyopathy (ejection fraction \\[EF\\] \\\u003C 50%).\n* Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy).\n* Unable to swallow capsules, has a partial or small bowel obstruction, or has a gastrointestinal condition resulting in a malabsorptive syndrome (e.g. small bowel resection with malabsorption).\n* Active peptic ulcer disease.\n* Other active malignancy except for localized skin cancer, bladder, prostate, breast or cervical carcinoma in situ.\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":187,"type":21},30,[143],"This phase I trial tests the safety, side effects, and best dose of a new 8-chloroadenosine in combination with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). 8-Chloroadenosine may help block the formation of growths that may become cancer. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving 8-chloroadenosine in combination with venetoclax may help prevent the disease from coming back in patients with acute myeloid leukemia.",[191,192,193],"Acute Myeloid Leukemia","Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia",{"date":33,"type":34},{"date":196,"type":34},"2022-10-31",{"date":198,"type":21},"2029-01-25",{"name":40,"class":41},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":52,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"100387804","phase-1-pipac-for-the-treatment-of-peritoneal-carcinomatosis-in-patients-with-ovarian-uterine-appendiceal-colorectal-or-gastric-cancer-100387804","NCT04329494","PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer","Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC\n* Prior IP chemotherapy is permitted\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 2\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3\n* Platelets \\>= 100,000\u002Fmm\\^3\n* Hemoglobin \\>= 9 g\u002Fdl\n* Serum total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 2.5 x ULN, unless liver metastases (Arm 1) are present or unless patients is know to have chronic liver disease (hepatitis) in which case AST and ALT must be =\\\u003C 5 x ULN\n* Alkaline phosphatase =\\\u003C 2 x ULN\n* Serum creatinine (sCr) =\\\u003C 1.5 x ULN, or creatinine clearance (Ccr) \\>= 40 ml\u002Fmin as calculated by the Cockcroft-Gault formula\n* No contraindications for a laparoscopy\n* The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to be visible on cross sectional imaging or diagnostic laparoscopy\n* Patients must have progressed on at least one evidence-based chemotherapeutic regimen (Arm 1 and 2). For Arm 3, patients should have stable or responsive disease on at least 4 months first-line systemic chemotherapy\n* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is define as:\n\n  * Amenorrhea \\>= 12 consecutive months without another cause or\n  * For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL\n  * Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential\n* INCLUSION TO PROCEED WITH PIPAC: Laparoscopy findings must meet all of the below criteria in order to proceed to PIPAC:\n\n  * PIPAC access is feasible\n  * There is room for aerosol therapy\n  * There is no evidence of impending bowel obstruction\n  * =\\\u003C 5 L of ascites\n  * Not a candidate for cytoreduction and HIPEC\n\nExclusion Criteria:\n\n* Gastric and colorectal\u002Fappendiceal:\n\n  * Extra-peritoneal metastatic disease\n* Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and\u002For other anthracyclines and anthracenediones\n* Arm 2 (colorectal\u002Fappendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency\n* Arm 2 (colorectal\u002Fappendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition\n* Arm 2 (colorectal\u002Fappendiceal): Prior unanticipated severe reaction or hypersensitivity to platinum based compounds\n* Arm 2 (colorectal\u002Fappendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted\n* Arm 2 (colorectal\u002Fappendiceal): Life expectancy of less than 6 months\n* Arm 2 (colorectal\u002Fappendiceal): Chemotherapy or surgery within the last 4 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents\n* Arm 2 (colorectal\u002Fappendiceal): Previous anaphylactic reaction to the chemotherapy drug used\n* Arm 2 (colorectal\u002Fappendiceal): Patients may not be receiving any other investigational or concurrent anti-cancer agents\n* Arm 2 (colorectal\u002Fappendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis\n* Arm 2 (colorectal\u002Fappendiceal): Simultaneous tumor debulking with gastrointestinal resection\n* Arm 2 (colorectal\u002Fappendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment\n* Arm 2 (colorectal\u002Fappendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system\n* Arm 2 (colorectal\u002Fappendiceal): Involvement in the planning and conduct of the study\n* Arm 2 (colorectal\u002Fappendiceal): Pregnancy\n* Arm 2 (colorectal\u002Fappendiceal): Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Arm 2 (colorectal\u002Fappendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months\n* Arm 2 (colorectal\u002Fappendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug\n* Arm 2 (colorectal\u002Fappendiceal): Exclusive total parenteral nutrition\n* Arm 2 (colorectal\u002Fappendiceal): Prior intra-abdominal aerosol chemotherapy\n* Arm 3 (colorectal\u002Fappendiceal): Progression on first- AND second-line systemic therapy\n* Arm 3 (colorectal\u002Fappendiceal): Hematologic toxicities requiring significant dose reductions while on systemic chemotherapy\n* Arm 3 (colorectal\u002Fappendiceal): Intolerance to prior 5-FU at 2400mg\u002Fm\\^2 IV every 2 weeks or to irinotecan at 180mg\u002Fm\\^2. Intolerance is defined as the need of significant dose reduction or treatment interruption of \\> 1 week due to toxicity\n* Arm 3 (colorectal\u002Fappendiceal): Known DPD deficiency\n* Arm 3 (colorectal\u002Fappendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition\n* Arm 3 (colorectal\u002Fappendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted\n* Arm 3 (colorectal\u002Fappendiceal): Life expectancy of less than 6 months\n* Arm 3 (colorectal\u002Fappendiceal): Chemotherapy or surgery within the last 2 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents\n* Arm 3 (colorectal\u002Fappendiceal): Previous anaphylactic reaction to the chemotherapy drug used\n* Arm 3 (colorectal\u002Fappendiceal): Patients may not be receiving any other investigational anti-cancer agents\n* Arm 3 (colorectal\u002Fappendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis\n* Arm 3 (colorectal\u002Fappendiceal): Simultaneous tumor debulking with gastrointestinal resection\n* Arm 3 (colorectal\u002Fappendiceal): Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment\n* Arm 3 (colorectal\u002Fappendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system\n* Arm 3 (colorectal\u002Fappendiceal): Involvement in the planning and conduct of the study\n* Arm 3 (colorectal\u002Fappendiceal): Pregnancy\n* Arm 3 (colorectal\u002Fappendiceal): Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Arm 3 (colorectal\u002Fappendiceal): New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months\n* Arm 3 (colorectal\u002Fappendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug\n* Arm 3 (colorectal\u002Fappendiceal): Exclusive total parenteral nutrition\n* Arm 3 (colorectal\u002Fappendiceal): Prior intra-abdominal aerosol chemotherapy",{"count":208,"type":21},49,[143],"This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, 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. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and\u002For to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.",[212,213,214,215,100,101,216,102,217,218,219,220,221,103,222,223,224,225,226,227,228,229,230,231,232,233,104],"Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IVA Gastric Cancer AJCC v8","Clinical Stage IVB Gastric Cancer AJCC v8","Malignant Uterine Neoplasm","Metastatic Gastric Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Ovarian Carcinoma","Pathologic Stage IV Gastric Cancer AJCC v8","Peritoneal Carcinomatosis","Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IVA Appendix Carcinoma AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Appendix Carcinoma AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Stage IVC Appendix Carcinoma AJCC v8",{"date":62,"type":34},{"date":236,"type":34},"2020-08-21",{"date":238,"type":21},"2028-01-05",{"name":40,"class":41},3,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":52,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":42},"100639858","phase-2-total-marrow-and-lymphoid-irradiation-in-combination-with-fludarabine-and-melphalan-as-conditioning-for-allogeneic-peripheral-blood-stem-cell-hematopoietic-cell-transplant-in-older-patients-with-refractory-and-relapsed-acute-myeloid-leukemia-and-high-risk-myelodysplastic-syndrome-100639858","NCT07582172","Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome","Phase 2 Trial of Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplantation (PBSC-HCT) From a Match Donor With Fludarabine and Melphalan in Older Patients With Refractory Acute Myeloid Leukemia and MDS","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 50 years (no upper age limit)\n\n  * Note: Patients ≥ 18 years and \\\u003C 50 years are also included if they are not candidates for myeloablative conditioning regimens due to comorbidities or active disease\n* Karnofsky or Lansky performance status ≥ 70\n* Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories:\n\n  * Acute myeloid leukemia (AML):\n\n    * Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for AML i.e., monosomal karyotype, -5,5q-,-7,7q-,11q23-non t(9;11), inv (3), t(3;3), t(6;9), t(9;22) and complex karyotypes (≥ 3 unrelated abnormalities), or all patient in intermediate risk groups\n    * Patients with active disease:\n\n      * Morphologically\n      * Minimal residual disease (MRD) testing (MRD+ through flow cytometry, cytogenetics, or molecular assays)\n  * Myelodysplastic syndrome\u002Fchronic myelomonocytic leukemia (CMML) (MDS) with ≥ 10% blast\n* Patients must have an human leukocyte antigen (HLA) (A, B, C, and DRB1) identical sibling or a 8\u002F8 (A, B, C, and DR) allele matched unrelated donor who is willing to donate primed blood stem cells\n* Serum direct bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* If able to perform pulmonary function tests: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Meets institutional and federal requirements for infectious disease titer requirements\n\n  * Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Allogeneic stem cell transplant or autologous HCT within 1 year prior to day 1 of protocol therapy\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days of day 1 of protocol therapy\n\n  * Note: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted. These include hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs). TKIs can also be given up to 3-5 days before conditioning regimen\n* More than three previous lines of intensive chemotherapy, where the regimen intent was to induce remission\n* Co-enrollment in other clinical trials involving post-HCT maintenance interventions or any study with potential to affect disease-free survival is not allowed\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active infection not responding to antibiotics\n* Other active malignancy. Patients 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 are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":249,"type":21},35,[78],"This phase II trial tests the effect of total marrow and lymphoid irradiation (TMLI) in combination with fludarabine and melphalan as conditioning regimen in older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has not responded to previous treatment (refractory) and that has come back after a period of improvement (relapsed) and are undergoing a donor (allogeneic) peripheral blood stem cell (PBSC) hematopoietic cell transplant (HCT) from a matched related or unrelated donor. HCT is the only curative treatment for high-risk patients, but the side effects related to the current conditioning treatments limit the use to younger and more fit patients. TMLI is a targeted form of total body radiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Fludarabine blocks cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. It is a type of purine antagonist and a type of ribonucleotide reductase inhibitor. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their DNA and stopping them from dividing. Giving chemotherapy, such as fludarabine and melphalan, and TMLI before an allogeneic transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells to grow. When healthy stem cells from a related or unrelated donor, such as PBSC HCT, that closely match the patient's blood, are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets, an may help destroy any remaining cancer cells. Giving TMLI in combination with fludarabine and melphalan as conditioning treatment for an allogeneic PBSC HCT from a matched related or unrelated donor may be safe, tolerable, and\u002For effective in treating high-risk older patients with relapsed and refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.",[253,254,255,192,256,257,258,193,259,260,261],"Acute Myeloid Leukemia With Complex Karyotype","Myelodysplastic Chronic Myelomonocytic Leukemia","Myelodysplastic Syndrome","Recurrent Myelodysplastic Chronic Myelomonocytic Leukemia","Recurrent Myelodysplastic Syndrome","Recurrent Secondary Acute Myeloid Leukemia","Refractory Myelodysplastic Chronic Myelomonocytic Leukemia","Refractory Myelodysplastic Syndrome","Refractory Secondary Acute Myeloid Leukemia","2026-08-18",{"date":62,"type":34},{"date":265,"type":21},"2027-04-05",{"date":267,"type":21},"2029-04-05",{"name":40,"class":41},{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":42},"100610328","prediction-of-neoadjuvant-chemotherapy-response-in-pancreatic-cancer-100610328","NCT07226154","Prediction of Neoadjuvant Chemotherapy Response in Pancreatic Cancer","An Exosomal miRNA Based Predictive Model for Personalized Neoadjuvant Chemotherapy Selection in Pancreatic Ductal Adenocarcinoma","PRECEPT","Inclusion Criteria:\n\n* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).\n* Underwent neoadjuvant chemotherapy (FOLFIRINOX or Gemcitabine\u002Fnab-paclitaxel).\n* Availability of pre-treatment plasma samples.\n* Underwent curative-intent resection (R0 or R1).\n\nExclusion Criteria:\n\n* Inadequate plasma samples or poor RNA quality for exosomal miRNA analysis.\n* Non-adenocarcinoma histology.\n* Presence of synchronous or multiple primary malignancies.\n* Receipt of chemotherapy regimens other than standard FOLFIRINOX or gemcitabine plus nab-paclitaxel (GEM-NABP).\n* Presence of active inflammatory or autoimmune diseases.",{"count":278,"type":21},200,"This study aims to develop and validate a predictive microRNA (miRNA) panel to assess the response to neoadjuvant chemotherapy (NACT) in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC).",[281],"Pancreatic Ductal Adenocarcinoma",[283,284,285,286,287,288],"PDAC","Exosome","miRNA","FOLFIRINOX","gemcitabine plus nab-paclitaxel","neoadjuvant chemotherapy",{"date":31,"type":34},{"date":291,"type":34},"2024-11-15",{"date":293,"type":21},"2026-12-01",{"name":40,"class":41},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":17,"minAge":302,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":311,"leadSponsor":312,"locationsCount":42},"100610213","exercise-and-mortality-in-middle-aged-and-older-adults-100610213","NCT07224659","Exercise and Mortality in Middle-Aged and Older Adults","Exercise and Mortality in Middle-Aged and Older Adults: A Target Trial Emulation","* Adults enrolled into the PLCO screening trial.\n* Among participants reporting low exercise at Q0 (i.e., 0 or less than 1 day\u002Fweek, with each session \\\u003C15 minutes in duration), completion of an exercise survey at Q1 as part of PLCO standard trial procedures no later than 5 years after reporting non-exercising status \\[i.e., no exercise) at Q0.\n* No evidence of any of the following absolute contraindications to exercise: uncontrolled hypertension, symptomatic valvular disease; hypertrophic cardiomyopathy; unstable angina pectoris; primary pulmonary hypertension; heart failure; severe arrhythmia; diagnosed dementia; any form of cancer other than non-melanoma, and severe infectious disease.","55 Years","74 Years",{"count":305,"type":21},19000,"This protocol is a retrospective study using the observational data of the the Prostate, Lung, Colorectal, and Ovarian (PLCO) screening trial with over 150,000 participants aged 55-74 years to conduct a target trial emulation to examine the association between self-reported exercise and all cause and cause-specific mortality in apparently healthy, middle-aged and older adults. The PLCO includes assessments of participants' exercise level at two timepoints: at randomization into the PLCO trial (Q0) and 5-7 years after randomization into the PLCO (Q1).",[308],"Overall Survival (All-cause Mortality)",{"date":31,"type":34},{"date":64,"type":21},{"date":293,"type":21},{"name":40,"class":41},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":52,"phases":322,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":42},"100495649","spatiotemporal-stereotactic-body-radiation-therapy-for-the-treatment-of-patients-with-polymetastatic-solid-tumors-100495649","NCT05733949","Spatiotemporal Stereotactic Body Radiation Therapy for the Treatment of Patients With Polymetastatic Solid Tumors","A Pilot Study of Spatiotemporal SBRT for Poly-Metastatic Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: \\>= 18 years\n* Karnofsky performance status \\> 60\n* Poly-metastatic disease, \\> 5 lesions, and with at least one lesion \\> 2.0 cm, with limited treatment options, and ineligible for or in progression under the standard systemic therapy\n* Pre-screening assessment confirms that the intervention can be administered without exceeding dose constraint guidelines\n* Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and follow up magnetic resonance imaging (MRI) 3 months after treatment shows stable findings\n* Spinal cord metastases are allowed as long as treatment with or without radiation is completed\n* Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints\n* Life expectancy \\>= 3 months in the opinion of the treating investigators\n* Off systemic therapy for at least one month prior and one month after study intervention\n\nExclusion Criteria:\n\n* Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements\n* Those not eligible for SBRT after review by a radiation oncologist\n* Serous medical comorbidities precluding radiotherapy\n* Unable to undergo a CT scan\n* Pregnant and\u002For breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects. Female patients of childbearing potentially must have a negative urine or serum pregnancy test within 72 hours prior to receiving therapy\n* On active systemic therapy\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":321,"type":21},20,[323],"EARLY_PHASE1","This clinical trial evaluates the safety and effectiveness of spatiotemporal stereotactic body radiation therapy (ST-SBRT) in treating patients with solid tumors that have spread to other parts of the body (polymetastatic). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. ST-SBRT is designed to deliver radiation directly to the core of the tumor, while keeping the radiation exposure of the area around the tumor at minimal dosage.",[217],{"date":31,"type":34},{"date":328,"type":34},"2023-04-27",{"date":330,"type":21},"2027-10-11",{"name":40,"class":41},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":164,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":348,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":352,"locationsCount":42},"100422017","study-to-detect-changes-in-urinary-and-gut-microbiome-during-androgen-deprivation-therapy-and-radiation-therapy-in-patients-with-prostate-cancer-100422017","NCT04775355","Study to Detect Changes in Urinary and Gut Microbiome During Androgen Deprivation Therapy and Radiation Therapy in Patients With Prostate Cancer","Pilot Study to Describe Changes in Urinary and Gut Microbiome During Androgen Deprivation and Radiation Therapy for Prostate Cancer","Inclusion Criteria:\n\n* Pathologically confirmed prostate cancer, with a plan to receive radiation therapy for either definitive (cohort A) or salvage (cohort B) therapy. Patients without planned androgen deprivation therapy (ADT) will be accrued to cohort C\n\n  * Cohort A will be restricted to Gleason grade group 3 or higher (4+3 or 8-10) so that androgen deprivation will be indicated\n  * Cohort B will not be restricted by Gleason grade but will require rising prostate-specific antigen (PSA) and a plan for ADT with salvage radiation\n  * Cohort C will be prostate cancer patients in whom definitive or salvage radiation is planned without ADT\n* Patients must be age 18 or older\n* Willing to provide urine and stool samples at specified time points\n\nExclusion Criteria:\n\n* Men with inflammatory bowel disease or pre-existing cystitis will be excluded",{"count":187,"type":21},"This study collects urine and stool samples to determine the ability to identify changes in the microbiome (bacteria, fungi, and viruses that live in the gut and urine) of patients with prostate cancer during androgen deprivation therapy and radiation therapy. Radiation therapy has the potential to harm the genitourinary area or the bowel, causing a feeling of urgency or increased inflammation in the area. The radiation therapy is designed to not irradiate the bowel and bladder areas, but there is still some radiation exposure. The gut microbiome has been associated with differences in inflammation as well as producing molecules that influence healing. The purpose of this study is to see whether the microbiome may contribute to the healing of the organs exposed to radiation. Information learned from this study may help researchers discover a new risk factor that could be manipulated to improve the quality of life in patients with prostate cancer.",[342,343,344,345,346,347],"Stage I Prostate Cancer AJCC v7","Stage II Prostate Cancer AJCC v7","Stage IIA Prostate Cancer AJCC v7","Stage IIB Prostate Cancer AJCC v7","Stage III Prostate Cancer AJCC v7","Stage IV Prostate Cancer AJCC v7",{"date":31,"type":34},{"date":350,"type":34},"2021-04-14",{"date":293,"type":21},{"name":40,"class":41},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":119,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":52,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":42},"100652581","tear-fluid-for-the-detection-of-tumor-associated-extracellular-vesicles-in-glioblastoma-patients-100652581","NCT07775534","Tear Fluid for the Detection of Tumor-associated Extracellular Vesicles in Glioblastoma Patients","Molecular Analysis of Tear Fluid Collected From Glioblastoma Patients: A Two-Phased Pilot Study","Inclusion Criteria:\n\n* Adults (age ≥ 18)\n* Male and female\n* All racial and ethnic groups\n* Pathologically-proven diagnosis of GBM or healthy volunteers\n* For GBM patients, presence of a previously placed Rickham reservoir or shunt\n* Able to provide informed consent (or via legal representative)\n* Willing to undergo Schirmer strip procedure\n\nExclusion Criteria:\n\n* Active ocular infection or inflammation\n* Recent ocular surgery (within 3 months)\n* Chronic dry eyes\n* Known allergy or hypersensitivity to topical anesthetics\n* Cognitive impairment\n* Pregnancy\n* Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study procedures or place the participant at undue risk",{"count":187,"type":21},[54],"This clinical trial tests the impact of tear fluid in detecting tumor-associated extracellular vesicles (TEVs) in patients with glioblastoma. Brain tumors release small particles, called TEVs, that may provide information about the tumor, including how it responds to treatment. These particles can be found in cerebrospinal fluid (CSF), which is the fluid that surrounds the brain and spinal cord. Collecting CSF can be difficult and expensive, especially if samples are needed frequently to track these particles over time. Tear fluid is easier to collect than spinal fluid. If tears are found to contain similar tumor-related particles, changes in the tumor may be tracked by studying the particles found in tear fluid.",[364],"Glioblastoma","2026-08-17",{"date":62,"type":34},{"date":368,"type":21},"2026-12-09",{"date":370,"type":21},"2027-09-19",{"name":40,"class":41},{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":164,"minAge":18,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":52,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":42},"100651975","magnetic-resonance-guided-stereotactic-body-radiation-therapy-for-the-treatment-of-prostate-cancer-100651975","NCT07769372","Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Prostate Cancer","A Pilot Study of Focal Magnetic Resonance (MR)-Guided Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For Legally Authorized Representative\n\n  * Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* National Comprehensive Cancer Network (NCCN) low-risk or intermediate-risk prostate cancer, defined as:\n\n  * Low-risk: Prostate-specific antigen (PSA) \\\u003C 10 ng\u002FmL AND grade group 1 (Gleason score 3+3) AND clinical stage T1-T2a\n  * Intermediate-risk (one or more of the following intermediate risk factors \\[IRFs\\]): PSA 10-20 ng\u002FmL, grade group 2 or 3 (Gleason 3+4 or 4+3), or clinical stage T2b-T2c\n\n    * Favorable intermediate-risk (all of the following): 1 IRF, grade group 1 or 2, \\\u003C 50% cores positive\n    * Unfavorable intermediate-risk (one or more of the following): 2 or 3 IRFs, grade group 3, ≥ 50% cores positive\n\n      * Biopsies from a single region of interest (ROI) are counted as a single sample\n* Diagnostic multiparametric MRI (mpMRI) of the prostate (within 6 months prior to enrollment) with MRI-visible dominant lesion defined as Prostate Imaging-Reporting and Data System (PI-RADS) ≥ 3\n* Prostate biopsy, including targeted and systematic biopsy. All PI-RADS ≥ 3 lesions must be sampled by MRI-targeted biopsy. Biopsy results must confirm concordance between the MRI-visible lesion and histologically confirmed prostate adenocarcinoma. Patients with any positive biopsy core (any grade group) from a region not attributable to the MRI-defined PI-RADS ≥ 3 lesion(s) are excluded\n* Unilateral disease, defined as: the MRI-visible dominant lesion(s) and all biopsy-confirmed prostate cancer confined to one prostatic lobe. Multiple lesions are permitted provided they can be encompassed within a single focal treatment planning volume\n* Agreement by males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Chemotherapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy\n* Current or planned androgen deprivation therapy (ADT), including leutenizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, antiandrogens, or prior bilateral orchiectomy. Prior 5-alpha reductase inhibitor use is permitted if discontinued ≥ 90 days prior to baseline PSA assessment or if the corrected PSA value (measured PSA × 2) meets protocol risk group eligibility criteria (≤ 20 ng\u002FmL)\n* Prior focal therapy for prostate cancer, including but not limited to high intensity focused ultrasound (HIFU), cryotherapy, irreversible electroporation (IRE), laser ablation, or photodynamic therapy\n* Prior pelvic radiation therapy\n* Prior prostate procedures for BPH (including but not limited to transurethral resection of the prostate \\[TURP\\], UroLift, Aquablation, Rezūm, prostate artery embolization) that, in the opinion of the treating radiation oncologist, have significantly altered prostatic anatomy such that focal SBRT treatment planning would be compromised or leads to increased risk of treatment-related toxicity\n* For patients with severe baseline lower urinary tract symptoms (International Prognostic Scoring System \\[IPSS\\] ≥ 20), the treating radiation oncologist should confirm that the patient's baseline urinary function and location\u002Fvolume of target does not, in their clinical judgment, represent an unacceptable risk for treatment-related urinary morbidity\n* Clinically significant uncontrolled illness. Patients that are known to be HIV-infected that are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Patient has baseline grade ≥ 3 gastrointestinal (GI) or genitourinary (GU) toxicity\n* History of prior rectal surgery (e.g., low anterior resection, abdominoperineal resection) or other pelvic surgery that, in the opinion of the treating radiation oncologist, would significantly alter normal pelvic anatomy and compromise safe treatment delivery\n* Active inflammatory bowel disease (ulcerative colitis or Crohn's disease) involving the rectum or sigmoid colon\n* Contraindication to magnetic resonance imaging, including but not limited to:\n\n  * Implanted metallic devices not certified as MRI-conditional (e.g., non-MRI-conditional cardiac pacemakers, defibrillators, neurostimulators, cochlear implants, metallic foreign bodies)\n  * Severe claustrophobia not manageable with anxiolytic medication and\u002For supportive measures\n  * Inability to tolerate supine positioning for the duration of MR-guided treatment delivery (approximately 30-45 minutes per fraction)\n* Other active malignancy. Patients 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 are eligible for this trial\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":321,"type":21},[54],"This clinical trial studies the side effects and how well magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. MR-guided SBRT uses magnetic resonance imaging (MRI) to define and localize the area to be treated, which may help provide more accurate delivery of SBRT and lower side effects. MR-guided SBRT may be safe, tolerable, and\u002For effective in treating patients with prostate cancer.",[383,384,385,386,387],"Stage I Prostate Cancer AJCC v8","Stage II Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","2026-08-14",{"date":365,"type":34},{"date":391,"type":21},"2027-01-01",{"date":393,"type":21},"2029-03-09",{"name":40,"class":41},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":164,"minAge":402,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":52,"phases":406,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":42},"100608491","phase-2-metabolic-interventions-time-restricted-eating-glp1-receptor-agonist-and-heart-healthy-diet-to-improve-cardiometabolic-health-in-prostate-cancer-patients-during-androgen-deprivation-therapy-impact-adt-trial-100608491","NCT07202247","Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostate Cancer Patients During Androgen Deprivation Therapy, IMPACT-ADT Trial","A Phase II Randomized Study of Interventions for Metabolic Protection Against Cardiometabolic Toxicity During Androgen Deprivation Therapy (IMPACT-ADT)","Inclusion Criteria:\n\n* Documented informed consent of the participant\n* English, Spanish or Mandarin-speaking\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Male\n* Aged: 30-79\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n* High burden of cardiovascular comorbidities who would be eligible for insurance coverage for GLP1-RA therapy defined as:\n\n  * Body mass index (BMI) of ≥ 30 kg\u002Fm\\^2 or\n  * BMI ≥ 27 kg\u002Fm\\^2 in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, dyslipidemia)\n* Prostate cancer defined as one of the following:\n\n  * National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer receiving definitive radiation with a plan to undergo ADT for 6 months\n  * Biochemical persistent or recurrent prostate cancer status post prostatectomy receiving salvage radiation with a plan to undergo ADT for 6 months\n\nExclusion Criteria:\n\n* Currently engaging in strict macronutrient\u002Ftime limited diet, including ketogenic, low-carb, paleo, or warrior diet\n* Currently under GLP1-RA therapy\n* Poorly controlled diabetes\n* Unable to undergo time-restricted diet\n* Contraindications for GLP1-RA therapy: including hypersensitivity to the drug, personal history of pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2, end-stage renal disease\n* Other active disease deemed not eligible to participant in the study according to treating physician\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","30 Years","79 Years",{"count":405,"type":21},60,[78],"This phase II trial compares the effect of time-restricted eating (TRE) and glucagon-like peptide-1 (GLP1) receptor agonists (RA), semaglutide and tirzepatide, to an American Heart Association (AHA) heart healthy diet (HHD) intervention on heart and blood vessel health (cardiovascular system) and how the body processes food for energy (metabolic system) in prostate cancer patients undergoing androgen deprivation therapy (ADT). Prostate cancer patients who are receiving hormonal therapy (ADT) are at an increased risk of cardiovascular disease. This is thought to be due to treatment-related metabolic changes which may result in increased weight, body fat, insulin resistance and an increased risk of heart attack, stroke or other heart and blood vessel problems. TRE (also known as intermittent fasting) is an eating plan that alternates between fasting and non-fasting periods. This approach limits calorie intake to a specific window of time each day. GLP1-RAs, semaglutide and tirzepatide are in a class of medications called incretin mimetics. They work by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. They also slow the movement of food through the stomach and may decrease appetite and cause weight loss. The AHA HHD guidelines may be an effective method to help people learn about following a heart healthy eating plan. This may lower their risk of cardiovascular disease. Metabolic interventions, TRE and GLP1-RA, may be more effective than an AHA HHD intervention alone in improving cardiovascular and metabolic health in prostate cancer patients undergoing ADT.",[409,410],"Prostate Carcinoma","Recurrent Prostate Carcinoma","2026-08-13",{"date":365,"type":34},{"date":414,"type":34},"2025-11-05",{"date":416,"type":21},"2028-04-09",{"name":40,"class":41},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":425,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":52,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":42},"100456574","phase-1-modified-immune-cells-tag72-car-t-cells-for-the-treatment-of-patients-with-platinum-resistant-epithelial-ovarian-cancer-100456574","NCT05225363","Modified Immune Cells (TAG72-CAR T Cells) for the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer","A Phase 1 Study to Evaluate TAG72-Targeting Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced Epithelial Ovarian Cancer","ELIGIBILITY CRITERIA 1.1 Inclusion Criteria\n\n* Participant must have the ability to understand and the willingness to sign a written informed consent.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable exceptions may be granted with Study PI approval.\n* Age \\> 18 years.\n* ECOG Performance status 0 - 2 or KPS ≥70%.\n* Documented platinum resistant EOC (defined as disease that has progressed within six months of completing platinum therapy, or lack of response or disease progression while receiving the most recent platinum-based therapy, respectively). Progression may be determined radiographically (not RECIST) or by new onset of malignant pleural effusion. Participant may have at least 1 measurable lesion or disease measured by PCI at the time of surgery.\n* Documented TAG72+ (\\> 1% cells ≥ +1 intensity) tumor expression by IHC (MAb CC49) as evaluated by COH Pathology Core.\n* In addition to platinum agents, participant must have received and failed, or have been intolerant to taxanes, liposomal doxorubicin or other agents known to confer clinical benefit. Participants are not required to fail all of these chemotherapy agents if, in the investigator's opinion, they would benefit from treatment on the current protocol.\n* No known contraindications to leukapheresis, steroids or tocilizumab.\n* Participant of reproductive potential must agree to use acceptable birth control methods throughout study therapy and for 3 months after final dose of study treatment.\n* \\_ANC ≥ 1,000\u002Fmm3\n* Total serum bilirubin ≤ 1.5 x ULN Patients with Gilbert syndrome may be included if their total bilirubin is \\\u003C 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.\n* AST \\\u003C 3 x ULN if liver metastasis: AST \\\u003C 5 x ULN)\n* ALT \\\u003C 3 x ULN if liver metastasis: ALT \\\u003C 5 x ULN)\n* Participants not receiving therapeutic anticoagulation: INR or aPTT ≤1.5 x ULN\n* Creatinine clearance of ≥ 50 mL\u002Fmin per the Cockcroft-Gault formula\n* Cardiac function (12 lead-ECG) without acute abnormalities requiring investigation or intervention\n* Left ventricular ejection fraction \\>40%\n* QuantiFERON-TB Gold or equivalent\\*\n\n1.2 Exclusion Criteria\n\n* Participant has not yet recovered from toxicities of prior therapy.\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition or other agents used in this study.\n* History of (non-infectious or COVID-related) pneumonitis that required steroids or current pneumonitis\n* Current signs and\u002For symptoms of bowel obstruction\n* History of inflammatory bowel disease\n* History of gastrointestinal perforation or symptomatic diverticular disease\n* History of intra-abdominal abscess within the past 3 months.\n* Patients with known peritoneal adhesions that preclude the placement of an intraperitoneal catheter in the opinion of the surgeon placing the intraperitoneal catheter.\n* Participant with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of signing the 'Screening\u002FLeukapheresis\u002FTreatment' consent.\n* Participant with known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder.\n* Known bleeding disorders (e.g., von Willebrand's disease or hemophilia).\n* History of stroke or intracranial hemorrhage within 6 months prior to signing the 'Screening\u002FLeukapheresis\u002FTreatment' consent.\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent with no known active disease present for ≥ 3 years, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin.\n* Uncontrolled active infection.\n* Active hepatitis B or hepatitis C infection.\n* HIV infection.\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.\n\n  o Massive ascites requiring therapeutic paracentesis will not be cause for ineligibility, per se, but will be evaluated on an individual basis. Investigators who have questions regarding assessing ascites are asked to speak with the Principal Investigator.\n* Subject has received or plans to receive the following therapy\u002Ftreatment prior to leukapheresis or lymphodepleting chemotherapy, unless stopped according to the washout requirements:\n* Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).","FEMALE",{"count":427,"type":21},33,[143],"This phase I trial tests the safety, side effects, and best dose of TAG72-chimeric antigen receptor (CAR) T cells in treating patients with epithelial ovarian cancer that remains despite treatment with platinum therapy (platinum resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize TAG72, a protein on the surface of tumor cells. These TAG72-specific T cells may help the body's immune system identify and kill TAG72+ cancer cells.",[431],"Platinum-Resistant Ovarian Carcinoma",{"date":365,"type":34},{"date":434,"type":34},"2023-05-01",{"date":436,"type":21},"2028-11-05",{"name":40,"class":41},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":52,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":42},"100641026","phase-1-a-pet-imaging-agent-64cu-dota-pembrolizumab-for-determining-treatment-response-among-patients-with-stage-iv-non-small-cell-lung-cancer-receiving-pembrolizumab-100641026","NCT07619599","A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab","Pilot Study of 64Cu-DOTA Pembrolizumab (64CDP) in Patients Receiving Stereotactic Body Radiation Therapy (SBRT) for Oligo-Progressive Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed stage IV non-small cell lung cancer\n* Patients on single-agent pembrolizumab, who have been referred for SBRT for or oligo-progressive disease. A maximum of 6 sites will be allowed to receive SBRT on protocol\n* Patients must have sites that are amenable to SBRT that are located in lymph nodes, bone\u002Fspine, or lung\n* Brain metastases or cases with intra-cranial progression are allowed, but an additional extra-cranial site planned for SBRT is required\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n* Platelets ≥ 50,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Patient planned to stop pembrolizumab at time of referral for SBRT\n* Vaccination with live attenuated vaccines within 4 weeks of study agent administration except forthcoming coronavirus disease 2019 (COVID-19) and flu vaccines\n* Subject is currently using or has used immunosuppressive medication within 14 days prior to the study agent administration with the exception of:\n\n  * Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)\n  * Chronic systemic corticosteroids at physiologic doses not to exceed 5 mg\u002Fday of prednisone or equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., infusion-related reactions, CT scan premedication)\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Infection requiring systemic antibiotic therapy within 14 days prior to start of study treatment\n* Patient unable to tolerate PET scan even with anxiolytic medications\n* Other active metastatic malignancy. Patients 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 are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":446,"type":21},6,[143],"This phase I trial studies the safety and side effects of a new positron emission tomography (PET) imaging agent called 64Cu-DOTA-pembrolizumab to see how well it works in determining treatment response for patients with stage IV non-small cell lung cancer (NSCLC) already receiving pembrolizumab. 64Cu-DOTA-pembrolizumab consists of a monoclonal antibody, pembrolizumab, that binds to a protein called PD-1 that is expressed on tumor cells. PET scans can then visualize the tumor cells using 64Cu, a radioactive substance. 64Cu-DOTA-pembrolizumab PET scans may be safe and useful to doctors in telling the difference between tumors that are still growing and areas that are not growing in patients with stage IV NSCLC receiving pembrolizumab treatment.",[450,451,452,453],"Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Brain","Oligoprogressive Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8","2026-08-11",{"date":456,"type":34},"2026-08-12",{"date":458,"type":21},"2026-09-14",{"date":460,"type":21},"2028-12-22",{"name":40,"class":41},{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":52,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":483},"100602608","minimal-residual-disease-testing-for-the-early-detection-of-cancer-recurrence-in-resectable-stage-ii-iv-colorectal-cancer-patients-100602608","NCT07125729","Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients","ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison","Inclusion Criteria:\n\n* Documented written informed consent of the participant\n* Age: ≥ 18 years\n* Diagnosis of stage II, III or IV colorectal cancer (any gender) if enrolled post-operatively. If a treatment naïve patient is enrolled pre-operatively and determined to be pathological stage I, the patient will be replaced\n* Patient who are to undergo a curative intent surgery or have undergone a curative resection and are presenting for surveillance\n* Patient identified as an appropriate candidate for Signatera® testing as a standard of care MRD surveillance assay\n* Patient willingness to continue Signatera® assay every 3 months for 2 years in the first 2 years after resection and every 6 months for years 3, 4, 5 after resection, as performed by standard of care testing. In addition, the patients should be willing to provide blood samples for Haystack MRD testing at the same intervals of Signatera®, along with willingness to allow access to archival tissue to allow for Haystack MRD assay personalization. Surveillance with ctDNA should be initiated between 3 to 10 weeks from surgery\n* Adequate availability of archival tissue or anticipated pathological viable tissue. All untreated primary resection would be expected to have adequate tissue. Patients with resected metastatic disease should have either previously resected primary that is amenable for tumor informed MRD testing or should have adequate archival metastasectomy samples\n* Patients with total neoadjuvant therapy (TNT) for rectal cancer and complete clinical response with plans of watchful waiting may also be enrolled as long as there is adequate tissue from prior endoscopic biopsies to allow for Signatera® and Haystack MRD assays\n\nExclusion Criteria:\n\n* Inability to safely provide sequential blood samples\n* Clinical evidence of unresected metastatic disease\n* Inability to give informed consent",{"count":470,"type":21},150,[54],"This clinical trial compares minimal residual disease (MRD) testing with the Haystack blood test (assay) to the Signatera® assay for the early detection of the cancer returning (cancer recurrence) in patients with stage II-IV colorectal cancer (CRC) that can be removed by surgery (resectable). MRD testing looks for evidence of remaining tumor following treatment that is only apparent using highly sensitive techniques. There are few effective tools available outside of imaging to identify CRC patients with MRD who may be at the highest risk for cancer recurrence after surgery. Early detection of CRC recurrence after surgery is important, as it may increase the chance of curative (ability to cure) outcomes for patients with cancer recurrence. Currently, the Signatera assay is used to monitor whether CRC recurs after surgery, however it is not a very sensitive test. Early work with the Haystack assay suggests it may be more sensitive than the Signatera assay, which may be more effective for the early detection of cancer recurrence in patients with resectable stage II-IV CRC.",[474,475,476,222],"Resectable Colorectal Carcinoma","Stage II Colorectal Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8",{"date":456,"type":34},{"date":479,"type":34},"2025-08-29",{"date":481,"type":21},"2028-01-09",{"name":40,"class":41},13,{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":52,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":42},"100634846","phase-1-locoregional-administration-of-genetically-engineered-cells-egfril13r2-pool-car-t-cells-for-the-treatment-of-recurrent-or-progressive-high-grade-gliomas-100634846","NCT07544992","Locoregional Administration of Genetically Engineered Cells (EGFR\u002FIL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas","A Phase 1 Trial to Evaluate the Safety of EGFR\u002FIL13Rα2 Pool-CAR T Cells in Patients With Recurrent or Progressive High-Grade Glioma (HGG)","Main Inclusion Criteria\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval.\n* Age 18 years and older.\n* KPS ≥ 70%, ECOG ≤ 2 (Appendix A).\n* Life expectancy ≥ 4 weeks.\n* Participant has a prior histologically confirmed diagnosis of a glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or has a prior histologically confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 4 IDH-mutant astrocytoma.\n* Relapsed disease: radiographic evidence of recurrence\u002Fprogression of measurable disease after standard therapy (such as temozolomide with or without Optune device), and ≥ 12 weeks after completion of front-line radiation therapy.\n* COH Clinical Pathology assessment at the initial tumor presentation or recurrent disease (reference Appendix B):\n\n  * IL13Rα2+ expression by IHC \\> 20, and\n  * EGFR gene-altered by NGS or FISH analysis\n* No known contraindications to leukapheresis, steroids, imaging studies, or tocilizumab.\n* WBC \\> 2000 \u002Fdl (or ANC ≥ 1,000\u002Fmm3)\n* Platelets ≥ 75,000\u002Fmm3\n* Hemoglobin \\> 9g\u002FdL\n* Total bilirubin ≤ 1.5x ULN\n* AST ≤ 2.5x ULN\n* ALT ≤ 2.5x ULN\n* Serum creatinine ≤1.6 mg\u002FdL\n* O2 saturation ≥ 95% on room air.\n* Seronegative for HIV Ag\u002FAb combo, HCV, and active HBV\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test.\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of CAR T cells.\n\nMain Exclusion Criteria\n\n* Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded.\n* Participant has not yet recovered from toxicities of prior therapy.\n* Participant has received any live vaccine within 30 days prior to enrollment.\n* Uncontrolled seizure activity and\u002For clinically evident progressive encephalopathy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Clinically significant uncontrolled illness.\n* Active autoimmune disease requiring systemic immunosuppressive therapy\n* Active infection requiring IV antibiotics (for example, minor scalp infection is not exclusion).\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection.\n* Other active malignancy.\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":492,"type":21},24,[143],"This phase I trial studies the side effects and best dose of EGFR\u002FIL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). EGFR\u002FIL13Rα2 pool-CAR T cells are a type of CAR T cell therapy. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.",[496,497],"Recurrent Astrocytoma, IDH-Mutant, Grade 4","Recurrent Glioblastoma, IDH-Wildtype","2026-08-10",{"date":456,"type":34},{"date":501,"type":34},"2026-05-26",{"date":503,"type":21},"2031-11-04",{"name":40,"class":41},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":52,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":528},"100651201","phase-1-genetically-engineered-cells-baffr-car-t-cells-for-the-treatment-of-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia-and-b-cell-lymphoblastic-lymphoma-100651201","NCT07758673","Genetically Engineered Cells (BAFFR-CAR T Cells) for the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Lymphoblastic Lymphoma","A Phase 1 Study to Evaluate BAFFR-Targeting CAR T Cells for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Life expectancy ≥ 16 weeks\n* Histologically confirmed B-ALL or B-cell lymphoblastic lymphoma\n* Relapsed\u002Frefractory disease. Minimal residual disease (MRD) relapse is allowed\n* Evidence of tumor expressing BAFF-R at any level either by flow or immunohistochemistry\n* Recovered to ≤ grade 1 from the acute toxic effects (except alopecia and peripheral neuropathy) of prior anti-cancer therapy\n* No known contraindications to leukapheresis, steroids or tocilizumab\n* Ineligible for or failed prior CD19-targeted immunotherapy (e.g., blinatumomab or CD19-CAR T cells)\n\n  * For participants who had prior CD19-CAR T cell therapy:\n\n    * At least 90-days has elapsed since participant received last CD19-CAR T cell therapy AND\n    * Persistence of prior CD19-CAR T cells must be evaluated and found to be \\\u003C 5% prior to leukapheresis procedure\n    * Note: Participants who have undergone stem cell transplantation (at least 100 days prior to enrollment) after the last CD19-CAR T cell therapy, are considered eligible and do not need to meet the above criteria\n* Participants with central nervous system (CNS) involvement by leukemia (CNS2 and asymptomatic CNS3) may be considered eligible after discussions with the study team\n* Total serum bilirubin ≤ upper limit of normal (ULN) (unless has Gilbert's disease or related to liver involvement by leukemia, then ≤ 3.0)\n* Aspartate aminotransferase (AST) ≤ ULN, unless related to liver involvement by ALL, then ≤ 3.0\n* Alanine aminotransferase (ALT) ≤ ULN, unless related to liver involvement by ALL, then ≤ 3.0\n* Creatinine clearance of ≥ 40 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* Oxygen (O2) saturation ≥ 92% on room air\n* Seronegative for HIV quantitative polymerase chain reaction (qPCR), hepatitis C virus (HCV), and active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \\[RPR\\])\n\n  * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed OR\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. The viral load must be undetectable\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to start of protocol therapy\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* QuantiFERON-tuberculosis (TB) Gold or equivalent\n\n  * Results do not impact patient eligibility; however, the test must be initiated prior to enrollment\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* A complete liver evaluation (which includes ultrasound elastography, MRI of the liver and a hepatology consult) may be done if needed based on PI's recommendation\n\nExclusion Criteria:\n\n* Autologous\u002Fallogeneic stem cell transplant within 100 days at the time of enrollment\n* Immunosuppressant medications within 1 month prior to protocol enrollment\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone ≤ 7.5 mg \u002Fday or equivalent) is allowed\n* Auto-immune disease or active graft-versus-host disease (GvHD) within 3 months prior to protocol enrollment requiring systemic immunosuppressant therapy\n* Class III\u002FIV cardiovascular disability according to the New York Heart Association (NYHA) Classification\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within 2 weeks of enrollment\n* Any abnormal liver enzyme levels (as defined by grade 1 elevation from ULN in ALT, AST, and bilirubin levels) at time of enrollment, unless they are abnormal due to liver involvement by leukemia per the treating physician's discretion\n* Subjects with a known history or prior diagnosis of uncontrolled central nervous system (CNS) disorders such as optic neuritis or other immunologic or inflammatory disease affecting the CNS, including uncontrolled seizure disorder\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Known significant bleeding disorders (e.g., severe von Willebrand's disease) or hemophilia\n* History of venous occlusive disease (VOD), or GvHD\n\n  * Subjects with a history of the following GvHD may still be included in the study:\n\n    * Resolved grade 2 or less steroid-sensitive acute skin GvHD\n    * Grade 1 gastrointestinal (GI)-GvHD developed within 100 days post prior alloHCT\n    * Limited chronic GVHD\n* History of stroke or intracranial hemorrhage within 6 months of enrollment\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for ≥ 2 years\n* Clinically significant uncontrolled illness\n* Active systemic uncontrolled infection\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":513,"type":21},16,[143],"This phase I trial tests the safety and side effects of B-cell activating factor receptor (BAFFR) chimeric antigen receptor (CAR) T cells and how well they work in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) and B-cell lymphoblastic lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy, such as BAFFR-CAR T cells, is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving BAFFR-CAR T cells may be safe, tolerable and\u002For effective in treating patients with relapsed or refractory B-cell ALL and B-cell lymphoblastic lymphoma.",[517,518,519,520],"Recurrent B Acute Lymphoblastic Leukemia","Recurrent B Lymphoblastic Lymphoma","Refractory B Acute Lymphoblastic Leukemia","Refractory B Lymphoblastic Lymphoma","2026-08-06",{"date":454,"type":34},{"date":524,"type":21},"2027-04-17",{"date":526,"type":21},"2028-07-26",{"name":40,"class":41},2,{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":425,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":52,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":156},"100650009","a-blended-e-health-intervention-to-improve-fear-of-progression-in-women-with-gynecologic-or-breast-cancer-100650009","NCT07741968","A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer","An e-Health Intervention for Fear of Progression in Women With Gynecologic or Breast Cancer","Inclusion Criteria:\n\n* Women with stage III or IV GYN (ovarian, endometrial, cervical, vulvar\u002Fvaginal) or breast cancer who are at least 2 months from initial diagnosis OR Women with stage I or II endometrial, ovarian, or breast cancer with carcinosarcoma histology OR Women with stage I or II triple negative breast cancer\n* Score ≥ 34 on the Fear of Progression Short-Form, indicating dysfunctional levels\n* Age 18 or older; able to read and understand English\n* Patients can be on active treatment or surveillance. They can be no evidence of disease (NED), recurrent or with progressive disease\n\nExclusion Criteria:\n\n* Enrolled in hospice\n* Ongoing uncontrolled active psychiatric condition that, in the opinion of the investigator, would interfere in the conduct of the study (e.g., mood disorders, psychosis disorders, or substance use), Major depression as assessed by Patient Health Questionnaire-9 (PHQ-9)\n* Non-English speaking\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)\n* Current participation in a mind-body or mindfulness education program within the past six weeks",{"count":537,"type":21},126,[54],"This clinical trial studies whether an intervention supported by technology (blended e-health intervention) works to improve fear of progression (FOP) in women with gynecologic or breast cancer. FOP is the fear patients experience from the possibility that their cancer could grow, spread, or get worse. Managing FOP is a leading unmet concern of cancer patients. High levels of FOP are associated with distress, depression, and increased health care costs, despite this, access to resources to address FOP remain limited. The blended e-health intervention in this trial offers remote group sessions along with online sessions to help patients access the information. Session content incorporates values-based goal setting and skills practices to manage unhelpful beliefs about worry and promote helpful coping behaviors. The sessions may help patients recognize unhelpful thoughts and behaviors which reinforce worry. A blended e-health intervention may be an effective way to improve FOP in women with gynecologic or breast cancer.",[541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Breast Carcinoma","Breast Mixed Epithelial\u002FMesenchymal Metaplastic Carcinoma","Endometrial Carcinoma","Malignant Female Reproductive System Neoplasm","Ovarian Carcinoma","Ovarian Carcinosarcoma","Stage III Cervical Cancer AJCC v8","Stage III Vaginal Cancer AJCC v8","Stage III Vulvar Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Vaginal Cancer AJCC v8","Stage IV Vulvar Cancer AJCC v8","Triple-Negative Breast Carcinoma","Uterine Corpus Carcinosarcoma",{"date":498,"type":34},{"date":561,"type":21},"2027-02-22",{"date":563,"type":21},"2028-01-16",{"name":40,"class":41},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":52,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":582,"leadSponsor":584,"locationsCount":42},"100615499","phase-2-duvelisib-maintenance-for-the-treatment-of-peripheral-t-cell-lymphomas-100615499","NCT07293403","Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas","A Phase II Study of Duvelisib Maintenance After First-Line Therapy for Peripheral T-Cell Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed nodal T-follicular helper (TFH) cell lymphomas or PTCL-not otherwise specified (NOS). Nodal TFH cell lymphomas encompass three subtypes:\n\n  * Angioimmunoblastic T-cell lymphoma (AITL)(World Health Organization 4th edition revised \\[WHO4R\\])\u002Ffollicular helper T-cell lymphoma (TFH lymphoma), angioimmunoblastic type (International Consensus Classification \\[ICC\\])\u002Fnodal TFH cell lymphoma, angioimmunoblastic-type (World Health Organization 5th edition \\[WHO5\\])\n  * Nodal PTCL with TFH phenotype (nodal PTCL, TFH)(WHO4R)\u002FTFH lymphoma, NOS (ICC)\u002Fnodal TFH cell lymphoma, NOS (WHO5)\n  * Follicular T-cell lymphoma (FTCL)(WHO4R)\u002FTFH lymphoma, follicular type (ICC)\u002F nodal TFH cell lymphoma, follicular-type (WHO5)\n* Completion of first-line multi-agent chemotherapy with a cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP)-based regimen and documentation of complete response (CR) per Lugano criteria within the previous 6 months prior to enrollment. Prior corticosteroid monotherapy is not considered a line of therapy\n* Ineligible for or decline consolidative autologous stem cell transplantation. Ineligibility is defined by:\n\n  * Patient deemed ineligible for high-dose chemotherapy and ASCT based on physician's assessment\n  * AND at least one of the following criteria:\n\n    * Age ≥ 65 years or\n    * Age ≥ 18 years and Hematopoietic Cell Transplantation-specific Comorbidity Index score ≥ 3\n* Recovery to ≤ grade 1 or baseline for any toxicities due to prior treatments, with the exception of peripheral neuropathy (recovery to ≤ grade 2) or alopecia\n* Platelets ≥ 25,000\u002Fmm\\^3\n* Hemoglobin ≥ 8 g\u002FdL\n* CD4 lymphocyte count ≥ 50\u002Fmm\\^3 (0.05 × 10\\^9\u002FL)\n* Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (in patients with Gilbert's Syndrome a bilirubin \\> 1.5 × ULN but ≤ 3 × ULN may be allowed with sponsor approval)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 2.5 × ULN\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 × ULN\n* Serum creatinine ≤ 2.0 × ULN or creatinine clearance ≥ 30 mL\u002Fmin (estimated by Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] or Cockcroft-Gault equation or measured)\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR patients with presence of hepatitis B core antibody (HBcAb), but absence of hepatitis B surface antigen (HBsAg), are eligible if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable (\\\u003C 20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\n* Women of childbearing potential (WOCBP): negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months. Women who are considered not to be of childbearing potential are not required to have a pregnancy test\n* Agreement by females and males of reproductive potential (i.e., not surgically sterile or female patients who are not postmenopausal) must be willing to use a highly effective method of contraception for the duration of study treatment and for at least 1 months after the last dose of duvelisib\n\nExclusion Criteria:\n\n* Prior organ transplantation\n* Major surgery within 4 weeks prior to enrollment\n* Administration of a live vaccine within 30 days of cycle (C) 1 day (D) 1\n* Unable to receive prophylactic treatment for pneumocystis at enrollment\n* Use of medications or consumption of foods that are strong inducers or inhibitors of CYP3A must be discontinued at least 2 weeks prior to study intervention. Patients who (after enrollment) require use of a strong CYP3A4 inhibitor to treat a fungal\u002Fmold infection will require dose reductions\n* Known central nervous system involvement by PTCL\n* Patients with known diagnosis of\n\n  * Active cytomegalovirus (CMV) infection (patients with detectable viral load)\n  * History of tuberculosis treatment within 2 years prior to enrollment\n  * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for infection, but systemic treatment must be completed by cycle 1 day 1\n\n    * If a patient has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection, the patient must have a negative molecular (e.g., polymerase chain reaction \\[PCR\\]) test or 2 negative antigen test results at least 24 hours apart. Patients who do not meet SARS-CoV-2 infection eligibility criteria must be screen-failed and may only be rescreened if the following have been met:\n    * At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms\n* History of cirrhosis or chronic alcohol abuse\n* Symptomatic inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of duvelisib\n* Concurrent active malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver: nonmelanoma skin cancer, carcinoma in situ of the cervix\n* Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, such as pulmonary disease, including obstructive pulmonary disease and history of bronchospasm, uncontrolled diabetes, severe psychiatric disorder or unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI), stroke or unstable angina within the past 6 months\n  * New York Heart Association (NYHA) heart failure class III-IV\n  * Uncontrolled atrial fibrillation or hypertension\n* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to duvelisib\n* Participants who are receiving other investigational agents\n* Female patients who are breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":7,"type":21},[78],"This phase II trial tests how well duvelisib works as treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy (maintenance) for patients with peripheral T-cell lymphomas. Duvelisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells.",[576,577],"Follicular Helper T-Cell Lymphoma","Peripheral T-Cell Lymphoma, Not Otherwise Specified","2026-08-03",{"date":580,"type":34},"2026-08-05",{"date":64,"type":21},{"date":583,"type":21},"2027-11-23",{"name":40,"class":41},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":52,"phases":594,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":604,"leadSponsor":606,"locationsCount":42},"100610358","phase-2-ivonescimab-prior-to-surgery-for-the-treatment-of-high-risk-localized-clear-cell-renal-cell-cancer-100610358","NCT07226544","Ivonescimab Prior to Surgery for the Treatment of High-Risk Localized Clear Cell Renal Cell Cancer","A Phase II Study of Neoadjuvant Ivonescimab in Patients With High-Risk, Localized RCC","Inclusion Criteria:\n\n* Histologic confirmation of clear cell RCC\n* High-risk disease defined as cT2G3-4N0M0, cT3GanyN0M0, cT4GanyN0M0, cTanyGanyN+M0 (Grade determined by biopsy)\n* Candidate for partial or complete nephrectomy that extirpates all tumor tissue as part of treatment plan\n* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL (no blood transfusions or growth factor therapy used within 7 days of the screening complete blood count \\[CBC\\])\n* Platelet count ≥ 100 × 10\\^9\u002FL (no blood transfusions or growth factor therapy used within 7 days of the screening CBC)\n* Hemoglobin ≥ 9.0 g\u002FdL (no blood transfusions or growth factor therapy used within 7 days of the screening CBC)\n* Creatinine clearance (CrCL) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥ 60 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (adjustment by body surface area \\[BSA\\] is not required for eGFR)\n* Urine protein \\\u003C 2+ or 24-hour urine protein quantification \\\u003C 1.0 g\n* Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); For patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤ 3 × ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; For patients with liver metastases, AST and ALT ≤ 5 × ULN\n* Coagulation: Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose\n* Female patients of childbearing age must have negative serum pregnancy test results before enrollment or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing\n* Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab\n* Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab\n* Adults aged 18 years or older\n\nExclusion Criteria:\n\n* Prior systemic anti-tumor treatment for RCC\n* Major surgical procedures or serious trauma within 4 weeks prior to enrollment, or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to enrollment, including but not limited to:\n\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to enrollment is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone \\> 10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to enrollment, however the following will be allowed:\n\n  * Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted\n  * Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted\n* History of major diseases before enrollment, specifically:\n\n  * Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to enrollment, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before enrollment\n  * History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to enrollment\n  * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before enrollment\n  * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to enrollment\n* Imaging during the screening period shows that the patient has metastatic disease\n* Symptomatic central nervous system (CNS) metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to enrolment, potential need for CNS radiation within the first cycle, or leptomeningeal disease\n* Live vaccine or live attenuated vaccine within 4 weeks prior to planned enrolment, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted\n* Severe infection within 4 weeks prior to enrolment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to enrolment (excluding antiviral therapy for hepatitis B or C)\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5\n* Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic\n* History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease\n* Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled\n* Current use of systemic corticosteroids (\\> 10 mg daily prednisone or equivalent)\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to enrolment. All patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV ribonucleic acid \\[RNA\\] levels above the lower limit of detection) are excluded\n* Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies\n* History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Patient is breastfeeding or plans to breastfeed during the study\n* History of severe immune-mediated adverse events from immunotherapy agents (i.e. PD1\u002FPDL1\u002FCTLA4 inhibitors), or immune-related ocular toxicity, pneumonitis, or cardiomyopathy of any grade",{"count":593,"type":21},31,[78],"This phase II trial studies how well ivonescimab works prior to surgery in treating patients with high-risk clear cell kidney (renal cell) cancer that has not spread to other parts of the body (localized). Immunotherapy with monoclonal antibodies, such as ivonescimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivonescimab may also stop or slow the cancer by blocking the growth of new blood vessels necessary for tumor growth. Giving ivonescimab before standard surgery may make the tumor smaller.",[597,598,599,600,601],"Localized Clear Cell Renal Cell Carcinoma","Resectable Clear Cell Renal Cell Carcinoma","Stage II Renal Cell Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8",{"date":580,"type":34},{"date":64,"type":21},{"date":605,"type":21},"2027-09-08",{"name":40,"class":41},""]