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.