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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • 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.
  • Incidence of adverse events graded according to NCI CTCAE version 3.0 [ Time Frame: Up to 2 years ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 3, 2003
Date Started: November 2003
Date Completion:
Last Updated: October 7, 2013
Last Verified: October 2013