A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas
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.
Interventional
Primary Purpose: Treatment
Casilda Balmaceda, MD
Study Chair
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
CDR0000067449
NCT00004204
February 2000
Name | Location |
---|---|
Stanford University Medical Center | Stanford, California 94305-5408 |
Cancer Center of Albany Medical Center | Albany, New York 12208 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
Froedtert Memorial Lutheran Hospital | Milwaukee, Wisconsin 53226 |
Nalitt Institute for Cancer And Blood Related Diseases | Staten Island, New York 10305 |
Neurological Clinic | Portland, Oregon 97210 |