Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas|
|Study Start Date:||February 2000|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004204
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305-5408|
|United States, Florida|
|Mount Sinai Comprehensive Cancer Center|
|Miami Beach, Florida, United States, 33140|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, New York|
|Cancer Center of Albany Medical Center|
|Albany, New York, United States, 12208|
|Herbert Irving Comprehensive Cancer Center|
|New York, New York, United States, 10032|
|Nalitt Institute for Cancer And Blood Related Diseases|
|Staten Island, New York, United States, 10305|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Oregon|
|Portland, Oregon, United States, 97210|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Wisconsin|
|Froedtert Memorial Lutheran Hospital|
|Milwaukee, Wisconsin, United States, 53226|
|Study Chair:||Casilda Balmaceda, MD||Herbert Irving Comprehensive Cancer Center|