Temozolomide in Treating Patients With Brain Metastases
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 tumors metastatic to brain
Eligibility Criteria
DISEASE CHARACTERISTICS: Metastatic lesions to the brain Must not require immediate radiotherapy If received prior radiotherapy, must have progressive disease Evaluable disease by CT scan or MRI Neurologically stable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT or SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Blood urea nitrogen less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent nonmalignant systemic disease No acute infection requiring treatment with IV antibiotics HIV negative No frequent vomiting or medical condition that would preclude oral medication administration (e.g., partial bowel obstruction, inability to swallow) PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent hematopoietic growth factors, including epoetin alfa No other concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy, unless evidence of disease progression No other concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered Other: No other concurrent investigational drugs
Sites / Locations
- Duke Comprehensive Cancer Center