Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (Poly-ICLC)
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 adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma by biopsy or resection within the past 28 days 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 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN Renal Creatinine less than 1.5 mg/dL Other No significant medical illness that cannot be controlled adequately with appropriate therapy or that would compromise tolerability of study therapy No other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that disease for at least 3 years No active infection No disease that would obscure toxicity or dangerously alter drug metabolism No other serious concurrent medical illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior polifeprosan 20 with carmustine implant (Gliadel wafer) No concurrent chemotherapy Endocrine therapy Concurrent corticosteroids to treat symptoms or prevent complications are allowed Radiotherapy No prior radiotherapy to the brain No concurrent stereotactic radiosurgery No concurrent brachytherapy Surgery See Disease Characteristics Other No prior cytotoxic or noncytotoxic drug therapy for GBM No prior experimental drug therapy for GBM No other concurrent cytotoxic or noncytotoxic drug therapy for GBM Concurrent analgesics, antiepileptics, or other drugs to treat symptoms or prevent complications are allowed
Sites / Locations
- UCSF Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
poly-ICLC Newly diagnosed GBM
Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy Intramuscular injection Drug Poly-ICLC