A Phase I/II Trial of SU5416 in Patients With Recurrent High Grade Astrocytomas or Mixed Gliomas

Date de début de l'étude : 24 mars 2000

DISEASE CHARACTERISTICS: Histologically proven supratentorial malignant primary glioma, including: Glioblastoma multiforme Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma not otherwise specified Benign or malignant meningiomas, including brain and spinal meningiomas Patients with meningiomas are excluded from phase II portion of study Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or MRI Must have failed prior radiotherapy Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days Must be on stable (unchanged) dose of steroids for at least 5 days before scans Phase II: Must have completed radiotherapy at least 2 months prior to enrollment PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 8 weeks Hematopoietic: WBC at least 2,300/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: SGOT less than 2.5 times upper limit of normal Bilirubin normal No significant active hepatic disease Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min No significant active renal disease Cardiovascular: No uncompensated coronary artery disease on ECG or physical examination No history of myocardial infarction or severe/unstable angina within the past 6 months No deep venous or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 2 months after study No other serious concurrent illness No significant active psychiatric disease No diabetes mellitus with severe peripheral vascular disease No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No serious active infection No other concurrent disease that would obscure toxic effects or dangerously alter drug metabolism PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered No concurrent immunotherapy Chemotherapy: Phase I: No more than 2 prior chemotherapy regimens for recurrent disease Phase II: No more than 1 prior chemotherapy regimen for recurrent disease At least 2 weeks since prior vincristine At least 6 weeks since prior nitrosoureas At least 3 weeks since prior procarbazine Recovered from prior chemotherapy No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 3 weeks since prior endocrine therapy (e.g., tamoxifen) and recovered Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: Recovered from prior surgery Recent prior resection of recurrent or progressive tumor allowed Other: No other concurrent investigational agents