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 fenretinide in treating patients who have recurrent malignant glioma.
OBJECTIVES: I. Determine the efficacy of fenretinide as assessed by 6-month progression- free survival in patients with recurrent malignant glioma. II. Determine the rate of measurable clinical response, time to progression, and overall survival of patients treated with this drug. III. Determine the unexpected toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease type (glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001) vs anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed malignant glioma). Patients receive oral fenretinide twice daily during weeks 1 and 4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then before each course of chemotherapy. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 41-85 patients (21-45 with anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed malignant glioma and 20-40 with glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001)) will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
...and 1 more locations