Temozolomide in Treating Patients With Progressive Low-Grade Glioma
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal|
- Response rate
- Activity of temozolomide
|Study Start Date:||March 1998|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003466
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-4318|
|Study Chair:||Henry S. Friedman, MD||Duke Cancer Institute|