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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Given orally
Children's Oncology Group
Arcadia, California, United States
Best objective tumor response rates (complete and partial response), based on MRIs
Estimated ultimately as a simple binomial proportion. Estimated actuarially, using the product-limit (PL) estimate.
Time frame: Up to 2 years
Time to tumor progression (TTP)
The distribution of TTP will be analyzed using PL estimate.
Time frame: Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 2 years
Time to treatment failure (TTF)
The distribution of TTF will be analyzed using PL estimate.
Time frame: Time from study enrollment to tumor progression, tumor recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 2 years
Time to death (TTD)
The distribution of TTD will be analyzed using PL estimate.
Time frame: Time from study enrollment to death from any cause, assessed up to 2 years
Incidence of adverse events graded according to NCI CTCAE version 3.0
Time frame: Up to 2 years
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