CCI-779 in Treating Patients With Malignant Glioma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed intracranial malignant glioma
• * Glioblastoma multiforme
• * Anaplastic astrocytoma
• * Anaplastic oligodendroglioma
• * Anaplastic mixed oligoastrocytoma
• * Malignant astrocytoma not otherwise specified
• Initial diagnosis of low-grade allowed, if subsequently progressed
• Recurrent disease must have documented progression by MRI or CT scan
• Progressive disease must have failed prior radiotherapy
• Recent resection of recurrent or progressive tumor allowed provided all of the following are met:
• * Recovered from surgery
• * CT scan or MRI performed no more than 96 hours postoperatively OR at 4-6 weeks postoperatively
• * Concurrent steroid dosage must be stable
• Confirmation of true progressive disease (by PET, thallium scan, MR spectroscopy, or surgical documentation) required after prior interstitial brachytherapy or stereotactic radiosurgery
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• Karnofsky 60-100%
• Life expectancy:
• More than 8 weeks
• Hematopoietic:
• WBC at least 3,000/mm3
• Absolute neutrophil count at least 2,000/mm3
• Platelet count at least 120,000/mm3
• Hemoglobin at least 10 g/dL (transfusion allowed)
• Hepatic:
• Bilirubin less than 1.5 times upper limit of normal (ULN)
• SGOT less than 1.5 times ULN
• Cholesterol less than 350 mg/dL
• Triglycerides less than 400 mg/dL
• Renal:
• Creatinine less than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• Other:
• No active infection
• No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No significant medical illness that would preclude study
• No disease that would obscure toxicity or dangerously alter drug metabolism
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779 or allergy to or inability to receive antihistamines
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 weeks after study
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• At least 1 week since prior interferon
• Chemotherapy:
• At least 2 weeks since prior vincristine
• At least 3 weeks since prior procarbazine
• At least 6 weeks since prior nitrosoureas
• Phase I:
• * 2 prior chemotherapy regimens allowed
• * 1 prior adjuvant regimen and 1 prior regimen for recurrent or progressive disease OR
• * 2 prior regimens for progressive tumor
• Phase II:
• * No more than 1 prior chemotherapy regimen for recurrent malignant glioma
• * No prior chemotherapy allowed for stable glioblastoma multiforme
• Endocrine therapy:
• See Disease Characteristics
• At least 1 week since prior tamoxifen
• Radiotherapy:
• See Disease Characteristics
• At least 4 weeks since prior radiotherapy for progressive disease
• No more than 1 month since prior radiotherapy for nonprogressive glioblastoma multiforme
• Surgery:
• See Disease Characteristics
• Other:
• Recovered from prior therapy
• At least 1 week since prior noncytotoxic agents