PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA

Fecha de inicio: 1 de septiembre de 1996

DISEASE CHARACTERISTICS: Pathologically confirmed recurrent malignant glioma for which surgery is indicated Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal Renal: Creatinine less than 1.5 times normal BUN less than 2.5 times normal Protein no greater than 3 g/dL No gross hematuria Other: No hypersensitivity to nitrosoureas Not pregnant Fertile patients must use effective contraception No concurrent life threatening disease PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy during first 8 weeks of study Chemotherapy: At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) No concurrent chemotherapy during first 8 weeks of study Endocrine therapy: Not specified Radiotherapy: Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required No concurrent radiotherapy or brachytherapy during first 4 weeks of study Surgery: Prior cytoreductive surgery for supratentorial brain tumor required Biopsy alone not sufficient Other: No concurrent investigational therapy during first 8 weeks of study