Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00004204
- Lead Sponsor
- Herbert Irving Comprehensive Cancer Center
- 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 patients who have recurrent or progressive malignant glioma.
- Detailed Description
OBJECTIVES:
* Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
* Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
* Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme \[closed to accrual 11/30/01\] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).
Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
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 (10)
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Nalitt Institute for Cancer And Blood Related Diseases
🇺🇸Staten Island, New York, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
Neurological Clinic
🇺🇸Portland, Oregon, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States