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OncoMatch/Clinical Trials/NCT05535166

Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma

Is NCT05535166 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for medulloblastoma.

Phase 2RecruitingSt. Jude Children's Research HospitalNCT05535166Data as of May 2026

Treatment: Methotrexate · Cisplatin · Vincristine · Cyclophosphamide · Carboplatin · Topotecan · Etoposide · Pegfilgrastim · Filgrastim · MethotrexateThis is a multi-center, multinational phase 2 trial that aims to explore the use of molecular and clinical risk-directed therapy in treatment of children 0-4.99 years of age with newly diagnosed medulloblastoma.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Disease stage

Required: Stage M2, M3, M4

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiotherapy

no previous radiotherapy

Cannot have received: chemotherapy

no previous chemotherapy

Cannot have received: cancer directed immunotherapy

no previous cancer directed immunotherapy

Cannot have received: targeted agents

no previous targeted agents

Lab requirements

Blood counts

ANC >750/mm^3; Platelet count ≥ 50,000/mm^3 without transfusion within 7 days; Hemoglobin ≥8.0 g/dL (with or without transfusion)

Kidney function

Serum creatinine: Age 0-<1y: ≤0.5 mg/dL; 1-<2y: ≤0.6 mg/dL; 2-<3y: ≤0.8 mg/dL

Liver function

ALT ≤ 135 U/L and total bilirubin ≤ 3 mg/dL

adequate organ function prior to study entry, as defined by: ANC >750/mm^3; Platelet count ≥ 50,000/mm^3 without support of a platelet transfusion within 7 days; Hemoglobin ≥8.0 g/dL (with or without support of a blood transfusion). Normal liver function as defined by ALT ≤ 3 x 45 U/L and total bilirubin ≤ 3 x 1.0. Adequate renal function as defined by a serum creatinine concentration: Age - 0 to <1year; Maximum Serum Creatinine (mg/dl) - Male 0.5; Female 0.5; Age - 1 to < 2years; Maximum Serum Creatinine (mg/dl) - Male 0.6; Female 0.6; Age - 2 to < 3years; Maximum Serum Creatinine (mg/dl) - Male 0.8; Female 0.8

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Lucille Packard Children's Hospital Stanford · Palo Alto, California
  • Orlando Health Arnold Palmer Hospital for Children · Orlando, Florida
  • St. Joseph's Children's Hospital · Tampa, Florida
  • C.S. MOTT Children's Hospital, University of Michigan · Ann Arbor, Michigan
  • Children's Hospital and Clinics of Minnesota · Minneapolis, Minnesota

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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