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.
Treatment: Methotrexate · Cisplatin · Vincristine · Cyclophosphamide · Carboplatin · Topotecan · Etoposide · Pegfilgrastim · Filgrastim · Methotrexate — This 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Disease stage
Required: Stage M2, M3, M4
Prior therapy
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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