Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Evaluation of Fenretinide NSC (374551) as a Single Agent in the Treatment of Adult Patients With Recurrent 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 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.
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