[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atypical-teratoid-rhabdoid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atypical-teratoid-rhabdoid-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":40,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100588487","early-phase-1-pilot-study-of-it-topotecan-and-maintenance-chemotherapy-for-hr-ebts-in-children--6-years-post-consolidation-100588487",false,"NCT06942039","Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children \u003C 6 Years, Post Consolidation","A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age","Inclusion Criteria:\n\n1. Tumor Tissue Sample\n2. Age: Patient must be aged ≥ 0 years to ≤ 6 years at the time of definitive confirmation of histologic diagnosis of eligible CNS tumor.\n3. Diagnoses. Participants must have Central nervous system (CNS) HR-EBT including atypical teratoid rhabdoid tumour (ATRT), group 3 and group 4 medulloblastoma (MB), pineoblastoma, CNS neuroblastoma, embryonal tumor with multi-layered rosettes (ETMR including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI-1 intact) and CNS embryonal tumor, not otherwise specified. Metastatic disease included. Any extent of resection included.\n4. Cranial and Spine MRI. A baseline MRI brain and spine with and without contrast is required for all patients. cranial MRI (with and without gadolinium) must be done pre-operatively. Post-operatively, cranial MRI (with and without gadolinium) must be done.\n5. Lumbar Puncture (LP) CSF for cytopathology (strongly recommended but not mandatory; if medically feasible). A baseline LP CSF cytology either pre-operatively or post-operatively at least 10 days after definitive surgery for all patients if medically feasible (This is not mandatory and will not make the patient ineligible).\n6. Life expectancy: Patients must have a life expectancy of greater than 8 weeks from diagnosis.\n7. Performance level: Patients must have a performance status corresponding of a Lansky score ≥ 50.\n8. Organ Function Requirements: Participants must have normal organ and marrow function as defined below:\n\nAdequate renal function defined as:\n\n\\- Creatinine clearance (12-24-hour urine collection) or radioisotope glomerular filtration rate (GFR) ≥ 60 ml\u002Fmin\u002F1.73m2\n\nAdequate cardiac function defined as:\n\n* Shortening fraction of ≥ 27% by echocardiogram, or\n* Ejection fraction of ≥ 47% by radionuclide angiogram.\n\nAdequate pulmonary function defined as:\n\n\\- No evidence of dyspnea at rest and a pulse oximetry \\> 94% on room air.\n\nAdequate Bone Marrow Function defined as:\n\n* Peripheral absolute neutrophil count (ANC) \\> 1000\u002FμL\n* Platelet Count \\> 100,000\u002FμL (without transfusion for 3 days)\n* Hemoglobin greater than 8 gm\u002FdL (may have received red blood cell (RBC) transfusions)\n\nAdequate liver function defined as:\n\n* Total bilirubin ≤ 1.5X upper limit of normal (ULN) within normal institutional limits for age (patients with documented Gilbert's Disease may be enrolled with Study Chair approval and total bilirubin ≤ 2.0 × ULN)\n* Alanine Aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 100 U\u002FL\n\nExclusion criteria:\n\n1. Patients who are receiving any other conventional anti-cancer agents or investigational agents.\n2. Patients who received previous therapy including radiotherapy or chemotherapy other than corticosteroids.\n3. Presence of another malignancy, except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.\n4. Concomitant medications restrictions: Concurrent use of enzyme inducing anticonvulsants (e.g. phenytoin, phenobarbital, and carbamazepine), selected strong inhibitors of cytochrome P450 3A4 include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John's wort or CYP450 3A4 stimulators or inhibitors.\n5. Other uncontrollable medical disease: Patient has a severe and uncontrollable medical disease (i.e., uncontrolled diabetes, hyperglycemia, chronic renal disease or active uncontrolled infection), has chronic liver disease (i.e., chronic active hepatitis and cirrhosis), hypercholesterolemia (serum cholesterol \\>300 mg\u002FdL), intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active hyperparathyroidism, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n6. Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or C.\n7. Ineligible diagnoses for study entry by neuropathology: This includes sonic hedgehog (SHH) and wingless (WNT) MBs, all ependymomas, all choroid plexus carcinomas, all high grade glial and glio-neuronal tumors, all diffuse midline gliomas, all primary CNS germ cell tumors, all primary CNS sarcomas, all primary or metastatic CNS lymphomas and solid leukemic lesions (chloromas, granulocytic sarcomas).\n8. The participant or parent(s)\u002Fguardian(s) cannot comply with the study visit schedule and other protocol requirements, in the investigator's opinion.\n\nAll patients must meet inclusion\u002Fexclusion criteria prior to starting any protocol therapy.","ALL","6 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Pilot study to determine feasibility of adding intrathecal chemotherapy and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"CNS Embryonal Tumor","CNS, Medulloblastoma","Atypical Teratoid Rhabdoid Tumor","Medulloblastoma, Childhood","Medulloblastoma, Group 3","Medulloblastoma, Group 4","Pineoblastoma","Neuroblastoma","Embryonal Tumor With Multilayered Rosettes","Embryonal Tumor With Abundant Neuropil and True Rosettes","Ependymoblastoma","Medulloepithelioma","CNS Embryonal Tumor With Rhabdoid Features","CNS Embryonal Tumor, Nos",[41],"HR-EBT","RECRUITING","2026-06-05",{"date":45,"type":46},"2026-06-08","ACTUAL",{"date":48,"type":46},"2025-09-23",{"date":50,"type":20},"2032-12-31",{"name":52,"class":53},"C17 Council","OTHER",12,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100632400","phase-1-gpc3-car-t-cells-with-il-15-and-il-21-for-recurrent-atrt-and-cns-rhabdoid-tumors-radiant-100632400","NCT07513194","GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT)","Robust Armored Dual-Cytokine (IL-15\u002FIL-21) GPC3-CAR T Cells for Atypical Teratoid Rhabdoid Tumors and Central Nervous System Rhabdoid Tumors (RADIANT)","Procurement Inclusion Criteria:\n\n* 1\\) Diagnosis of GPC3-positive recurrent ATRT.\n* 2\\) Age ≥ 6 months\n* 3\\) Karnofsky\u002FLansky score ≥ 60%\n* 4\\) Informed consent explained to, understood by, and signed by patient\u002Fguardian; copy provided\n* 5\\) GPC3 expression by immunohistochemistry with extent score ≥ Grade 2 (\\>25% positive tumor cells) and intensity score ≥ 2 (scale 0-4)\n\nProcurement Exclusion Criteria:\n\n* 1\\) No history of organ transplantation\n* 2\\) No known HIV positivity\n* 3\\) No active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* 4\\) No other risk factors in which administration of the investigational agent is deemed not in the patient's best interest, in the opinion of the investigator\n\nTreatment Inclusion Criteria:\n\n* 1\\) Age ≥ 6 months\n* 2\\) Diagnosis of treatment refractory or unresectable ATRT after standard of care therapy\n* 3\\) Lansky\u002FKarnofsky score ≥ 60%\n* 4\\) Stable neurologic exam for 7 days prior to enrollment\n* 5\\) Stable or decreasing dose of steroids over past 7 days prior to surgery and administration of therapy (max allowable dose is 0.1mg\u002Fkg dexamethasone or equivalent per day)\n* 6\\) Not receiving any concurrent anti-cancer therapy.\n* 7\\) At least 6 weeks following craniospinal radiation therapy.\n* 8\\) At least 14 days wash-out needed following small volume radiotherapy (i.e., Stereotactic Radiosurgery (SRS)).\n* 9\\) At least 21 days or 5 half-lives (whichever is shorter) must have elapsed since any prior systemic therapy\n* 10\\) Received any other forms of immunotherapy ≤ 42 days before administration of investigational agent\n* 11\\) At least 28 days following bevacizumab\n* 12\\) Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml\u002Fmin\n* 13\\) Total bilirubin \\\u003C 3 times ULN for age\n* 14\\) INR ≤ 1.7\n* 15\\) Absolute neutrophil count \\> 500\u002Fμl\n* 16\\) Platelet count \\> 100,000\u002Fμl (can be transfused but must be achieved prior to enrollment)\n* 17\\) Hgb ≥ 7.0 g\u002Fdl (can be transfused)\n* 18\\) Pulse oximetry \\> 90% on room air\n* 19\\) Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study\n* 20\\) Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.\n* 21\\) Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent\n\nTreatment Exclusion Criteria:\n\n* 1\\) Pregnancy or lactation (for women at child-bearing age, birth control is required)\n* 2\\) Uncontrolled infection\n* 3\\) Known HIV positivity\n* 4\\) Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* 5\\) History of organ transplantation","1 Year","21 Years",{"count":65,"type":20},21,[67],"PHASE1","This study is being conducted in patients with GPC3-positive brain tumors that have recurred or have not responded to standard therapy. Atypical teratoid rhabdoid tumors (ATRT) are aggressive tumors with poor outcomes and limited treatment options, particularly in young children. There is a need for new therapies that can improve outcomes while minimizing toxicity.\n\nThis study evaluates a new experimental treatment using genetically engineered T cells (RADIANT-T cells) that target glypican-3 (GPC3), a protein expressed on tumor cells. These T cells are modified to express a chimeric antigen receptor (CAR) targeting GPC3, along with IL-15 and IL-21 to enhance their persistence and activity. The cells also include an inducible safety mechanism (iCasp9) that allows them to be eliminated if necessary.\n\nThe purpose of this study is to determine the highest safe dose of RADIANT-T cells, evaluate their safety and side effects, assess how long they persist in the body, and determine whether they show anti-tumor activity in patients with GPC3-positive brain tumors.",[28,70],"Central Nervous System Rhabdoid Tumor",[72,73,74,28,75,76,77,78,79],"CAR T Cell Therapy","GPC3 CAR T Cells","Glypican-3","CNS Rhabdoid Tumor","Pediatric Brain Tumor","Adoptive Cellular Immunotherapy","Intracerebroventricular Immunotherapy","Solid Tumor CAR T Therapy","NOT_YET_RECRUITING","2026-04-01",{"date":83,"type":46},"2026-04-07",{"date":85,"type":20},"2026-09-01",{"date":87,"type":20},"2044-10-31",{"name":89,"class":53},"Baylor College of Medicine",1]