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 Conso

Protocol: 
AAAQ9270
Phase: 
IV

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 Conso

To determine, in a prospective randomized clinical trial, whether dose-intensive tandem Consolidation, in a randomized comparison with singe cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS) benefit for high-risk patients (non-Wnt and non-Shh sub- groups) with medulloblastoma, and for all patients with central nervous system (CNS) primitive neuro-ectodermal tumors (PNET) completing “Head Start 4” Induction, and if so, to 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. We hypothesize 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.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States