Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy
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, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme (GBM) Recurrent disease allowed Evaluable disease on contrast-enhanced MRI Prior external beam radiotherapy required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Cardiovascular: No significant cardiac disease No uncontrolled high blood pressure No unstable angina No congestive heart failure No myocardial infarction within the past 3 months No serious cardiac arrhythmias Gastrointestinal: Able to take oral medication No gastrointestinal abnormalities No requirement for IV alimentation No active peptic ulcer disease Other: No active infection No serious uncontrolled medical disorder No dementia or significantly altered mental status that would preclude study No known hypersensitivity to irinotecan or thalidomide Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception, including 1 highly effective method, at least 1 month before, during, and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior thalidomide Chemotherapy: No prior irinotecan At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease progression or relapse) Endocrine therapy: Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to study No concurrent hormonal therapy for GBM Radiotherapy: See Disease Characteristics No concurrent radiotherapy for GBM Surgery: No prior surgical procedures affecting absorption Other: No other concurrent anticancer investigational agents for GBM No concurrent cytochrome P450 inhibitors, including the following: Nefazodone Fluvoxamine Fluoxetine Sertraline Paroxetine Venlafaxine Ketoconazole Itraconazole Fluconazole Cimetadine Clarithromycin Diltiazem Erythromycin Protease inhibitors
Sites / Locations
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University