Head Start 4: Newly Diagnosed Children (Less Than 10 Years Old) With Medulloblastoma and Other Central Nervous System Primitive Neuro-Ectodermal Tumors: Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed By
This is a prospective randomized clinical trial, to determine whether dose- intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing Head Start 4 Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.
Are you Eligible? (Inclusion Criteria)
- Subjects must be 10 years of age or younger at the time of study entry.
- Patients must have been diagnosed with Medulloblastoma or Central Nervous System Embryonal Tumors of the brain or spinal cord.
- Patients must also meet all eligibility criteria as outlined in the study protocol.