Phase II Evaluation of Fenretinide NSC (374551) as a Single Agent in the Treatment of Adult Patients With 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.
Primary Purpose: Treatment
Vinay K. Puduvalli, MD
M.D. Anderson Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Simmons Cancer Center - Dallas||Dallas, Texas 75235-9154|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|