Spots Global Cancer Trial Database for Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
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Trial Identification
Brief Title: Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
Official Title: A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas
Study ID: NCT00004204
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford University Medical Center, Stanford, California, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Cancer Center of Albany Medical Center, Albany, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Nalitt Institute for Cancer And Blood Related Diseases, Staten Island, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Neurological Clinic, Portland, Oregon, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin, United States
Contact Details
Name: Casilda Balmaceda, MD
Affiliation: Herbert Irving Comprehensive Cancer Center
Role: STUDY_CHAIR
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