CCI-779 in Treating Patients With Malignant Glioma
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 anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
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
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
- UCSF Comprehensive Cancer Center
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Michigan Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- M.D. Anderson Cancer Center at University of Texas
- University of Texas Health Science Center at San Antonio
- University of Wisconsin Comprehensive Cancer Center