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

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.

Trial Location

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