Clinical Trials Directory

Trials / Completed

CompletedNCT00070525

Tipifarnib in Treating Young Patients With Recurrent or Progressive High-Grade Glioma, Medulloblastoma, Primitive Neuroectodermal Tumor, or Brain Stem Glioma

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGtipifarnibGiven orally

Timeline

Start date
2003-11-01
Primary completion
2006-09-01
First posted
2003-10-07
Last updated
2013-10-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00070525. Inclusion in this directory is not an endorsement.