Clinical Trial: Temozolomide in Treating Patients With Progressive Low-Grade Glioma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.
Detailed Summary:
OBJECTIVES:
- Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide.
- Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients.
OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma).
Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses.
Patients are followed every 8-12 weeks for 2 years.
PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.
Sponsor: Duke University
Current Primary Outcome:
- Response rate
- Activity of temozolomide
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Duke University
Dates:
Date Received: November 1, 1999
Date Started: March 1998
Date Completion:
Last Updated: July 7, 2014
Last Verified: February 2013
