Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed 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 adult mixed glioma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme or gliosarcoma Completed standard external beam radiotherapy within the past 5 weeks Stable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy More than 4 months Hematopoietic Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 No history of bleeding disorder Hepatic Bilirubin less than 1.5 mg/dL SGPT less than 2.5 times normal Alkaline phosphatase less than 2.5 times normal Renal BUN less than 1.5 times upper limit of normal (ULN) OR Creatinine less than 1.5 times ULN Cardiovascular No deep vein thrombosis within the past 3 weeks (must be clinically stable) Pulmonary No pulmonary embolism within the past 3 weeks (must be clinically stable) Other Must participate in System for Thalidomide Education and Prescribing Safety program No peripheral neuropathy grade 2 or greater No active infection No concurrent illness that may obscure toxicity or dangerously alter drug metabolism No other serious concurrent illness No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy No prior thalidomide No concurrent immunotherapy No concurrent prophylactic filgrastim (G-CSF) Chemotherapy No prior chemotherapy No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy Concurrent corticosteroids must be at stable or decreasing dose over the past 7 days Radiotherapy See Disease Characteristics No concurrent radiotherapy Surgery No concurrent surgery Other No other concurrent anticancer therapy No other concurrent investigational agents
Sites / Locations
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Cancer Center at the University of Virginia