Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00003464
- 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: Phase II trial to study the effectiveness of temozolomide in treating adults with newly diagnosed primary malignant glioblastoma multiforme.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States