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
Overview
- Phase
- Phase 2
- Intervention
- tipifarnib
- Conditions
- Childhood High-grade Cerebral Astrocytoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events graded according to NCI CTCAE version 3.0
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed brain tumor, including the following:
- •Anaplastic astrocytoma
- •Glioblastoma multiforme
- •Gliosarcoma
- •Anaplastic oligodendroglioma
- •Medulloblastoma/primitive neuroectodermal tumor (PNET)
- •Diffuse intrinsic brain stem glioma\*
- •Progressive or relapsed disease after prior conventional therapy
- •Radiographic evidence of measurable disease
- •Performance status - Karnofsky 60-100% (over 16 years of age)
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
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.
Intervention: tipifarnib
Outcomes
Primary Outcomes
Incidence of adverse events graded according to NCI CTCAE version 3.0
Time Frame: Up to 2 years
Best objective tumor response rates (complete and partial response), based on MRIs
Time Frame: Up to 2 years
Estimated ultimately as a simple binomial proportion. Estimated actuarially, using the product-limit (PL) estimate.
Time to tumor progression (TTP)
Time Frame: Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 2 years
The distribution of TTP will be analyzed using PL estimate.
Time to treatment failure (TTF)
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
The distribution of TTF will be analyzed using PL estimate.
Time to death (TTD)
Time Frame: Time from study enrollment to death from any cause, assessed up to 2 years
The distribution of TTD will be analyzed using PL estimate.