Sirolimus in Treating Patients With Glioblastoma Multiforme

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed intracranial glioblastoma multiforme
• Disease progression by MRI or CT scan
• * Confirmation of true progressive disease (not radiation necrosis) by positron-emission tomography, thallium scanning, MRI, or surgical documentation required if patient received prior interstitial brachytherapy or stereotactic radiosurgery
• Failed prior radiotherapy
• Phase I patients:
• * Eligible for salvage surgery
• * No limits on prior therapy
• Phase II patients:
• * Tumor progression by MRI or CT scan required within the past 14 days if recurrent disease is present
• * No prior therapy for more than 3 relapses
• * Recent resection of recurrent or progressive tumor allowed as long as all of the following conditions apply:
• * Recovered from surgery
• * MRI or CT scan performed no more than 96 hours since prior surgery OR within 4-6 weeks after surgery
• * Baseline MRI or CT scan performed within 14 days of study entry
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• Karnofsky 60-100%
• Life expectancy
• More than 8 weeks
• Hematopoietic
• WBC at least 3,000/mm\^3
• Absolute neutrophil count at least 2,000/mm\^3
• Platelet count at least 100,000/mm\^3
• 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
• Renal
• Creatinine less than 1.5 mg/dL
• Other
• Cholesterol less than 350 mg/dL
• Triglycerides less than 400 mg/dL
• No concurrent disease that would obscure toxicity or dangerously alter drug metabolism
• No other significant uncontrolled serious medical illness that would preclude study participation
• No other cancer except non-melanoma skin cancer or carcinoma in situ of the cervix unless patient is in complete remission and off all therapy for that disease for at least 3 years
• No active infection
• No prior allergic reactions to compounds of similar chemical or biological composition to sirolimus
• No psychiatric illness that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception
• 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
• Endocrine therapy
• At least 1 week since prior tamoxifen
• Radiotherapy
• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• Surgery
• See Disease Characteristics
• Other
• Recovered from prior therapy
• At least 1 week since prior noncytotoxic agents (except radiosensitizers)