Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.
|Brain and Central Nervous System Tumors||Drug: temozolomide Radiation: radiation therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal|
|Study Start Date:||September 1997|
|Study Completion Date:||August 2003|
- Determine the antitumor activity of temozolomide in adults with newly diagnosed glioblastoma multiforme.
- Define the relationship between tumor O6-alkylguanine-DNA alkyltransferase activity and tumor response in these patients.
- Define the relationship between tumor DNA mismatch repair activity and tumor response to temozolomide.
OUTLINE: Patients receive temozolomide orally once daily on days 1-5. Treatment courses are repeated every 28 days. In the absence of disease progression and toxicity, patients receive up to 4 courses of treatment prior to radiation therapy. After radiation therapy, patients demonstrating partial or complete response may receive an additional 12 courses of treatment.
Patients are followed every 8-12 weeks for 2 years.
PROJECTED ACCRUAL: This study will accrue 50 patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003464
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Henry S. Friedman, MD||Duke University|