Fenretinide in Treating Patients With Recurrent Malignant Glioma
Fenretinide in Treating 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.
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial malignant primary glioma
 Glioblastoma multiforme (closed to accrual as of 05/31/2001) Gliosarcoma (closed to accrual
 as of 05/31/2001) Anaplastic astrocytoma Anaplastic oligodendroglioma Mixed malignant
 gliomas Original histological diagnosis of low-grade glioma allowed if a subsequent
 histological diagnosis of malignant glioma is confirmed Prior treatment for no more than 2
 prior relapses allowed Disease progression documented by at least 2 pre-study brain scans
 Recent prior tumor resection of recurrent or progressive tumor allowed if recovered from
 the effects of prior surgery

 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
 expectancy: More than 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3
 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (may be transfusion
 dependent) Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than
 2 times ULN Renal: Creatinine less than 1.5 mg/dL Creatinine clearance at least 60 mL/min
 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
 barrier contraception during and for at least 2 months after study Able to swallow capsules
 No active infection No disease or other serious concurrent medical illness that would
 preclude study

 PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior interferon At least
 1 week since prior thalidomide Chemotherapy: Recovered from prior chemotherapy At least 4
 weeks since prior cytotoxic therapy (2 weeks for vincristine, 3 weeks for procarbazine, or
 6 weeks for nitrosoureas) Endocrine therapy: At least 1 week since prior tamoxifen Prior
 steroids allowed if on stable or decreasing dose for at least 5-7 days before baseline MRI
 If steroid dose is increased between date of baseline MRI and initiation of study drug, a
 new baseline MRI is required Radiotherapy: Not specified Surgery: See Disease
 Characteristics No concurrent surgery Other: At least 1 week since any prior noncytotoxic
 agents (e.g., isotretinoin) No other concurrent anticancer therapy, including other
 investigational drugs