Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

Inclusion Criteria

• •Age \> or = 18 years.
• •Karnofsky performance score \> or = 60.
• •Histopathologic confirmation of the diagnosis of a solid tumor malignancy. The brain metastasis diagnosis per se does not have to be pathologically confirmed if the clinical and neuro radiographic picture is typical.
• •MRI (or CT if the patient cannot undergo MRI) evidence of evaluable disease in the brain.
• •Absolute neutrophil count \> or = 1,500/mm³. Platelet count \> or = 100,000/mm³.
• •Hemoglobin \> or = 10 g/dl.
• •BUN and serum creatinine both \< 1.5 times upper limit of normal.
• •Total and direct bilirubin both \< 1.5 times upper limit of normal.
• •SGOT and SGPT both \< or = 3 times upper limit of normal.
• •Alkaline phosphatase \< or = 2 times upper limit of normal.
• •At least two weeks must have elapsed from brain biopsy, craniotomy, or other surgery.
• •Life expectancy \> or = 8 weeks.
• •Patient or their legal guardian or legal next-of-kin must provide written informed consent prior to patient's registration on study.
• •At least four weeks must have elapsed from previous external beam radiation therapy, or eight weeks from stereotactic radiosurgery.
• •Patients treated with radiosurgery should have evidence of progression at a distant site in the brain, or confirmation of tumor progression by biopsy or PET scan.