Recurrent Childhood Medulloblastoma Clinical Trial
Official title:
A Phase II Study of R115777 (Zarnestra) (NSC # 702818, IND# 58,359) in Children With Recurrent or Progressive: High Grade Glioma, Medulloblastoma/PNET or Brainstem Glioma
This phase II trial is studying how well tipifarnib works in treating young patients with recurrent or progressive high-grade glioma, medulloblastoma, primitive neuroectodermal tumor, or brain stem glioma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
OBJECTIVES:
I. Determine the response rate in pediatric patients with recurrent or progressive
high-grade glioma, medulloblastoma/primitive neuroectodermal tumor (PNET), or brain stem
glioma treated with tipifarnib.
II. Determine the distribution of time to progression, time to treatment failure, and time
to death in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
disease (high-grade glioma vs recurrent or progressive medulloblastoma/primitive
neuroectodermal tumor [PNET] vs progressive diffuse, intrinsic brain stem glioma).
Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days for
up to 2 years in the absence of disease progression or unacceptable toxicity.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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