Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy

You may be eligible if

• 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