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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.
Age
0 - 21 years
Sex
ALL
Healthy Volunteers
No
Children's Oncology Group
Arcadia, California, United States
Start Date
November 1, 2003
Primary Completion Date
September 1, 2006
Last Updated
October 8, 2013
90
ESTIMATED participants
tipifarnib
DRUG
Lead Sponsor
National Cancer Institute (NCI)
NCT02194452
NCT02175745
Data Source & Attribution
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