Temozolomide in Treating Patients With Progressive Low-Grade Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00003466
- Lead Sponsor
- Duke University
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate Activity of temozolomide
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States