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.
Screening Phase (All Patients)
Participants with presumptive/suspected newly diagnosed medulloblastoma.
Age < 36 months OR Age ≥ 36 months and < 60 months with presumptive/suspected non-metastatic disease
Participant must have adequate tumor tissue from primary tumor for central review of pathology and molecular classification by methylation and IHC
Screening Phase
Participants with other clinically significant medical disorders (i.e., serious infections or significant cardiac, pulmonary, hepatic, psychiatric, or other organ dysfunction) that could compromise their ability to tolerate protocol therapy or would interfere with the study procedure.
Participant must be < 60 months of age at time of enrollment.
Note: Each treatment stratum has additional specific age requirements
St. Jude Children's Research Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator