Sirolimus in Treating Patients With Glioblastoma Multiforme
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
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)
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1
Phase 2
See intervention description.
See intervention description.