Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

INCLUSION CRITERIAL:

• 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.

EXCLUSION CRITERIA:

• Previous treatment with temozolomide, dacarbazine or vinorelbine.
• Patients who have not recovered from all acute toxicities of prior therapies.
• Patients with evidence of leptomeningeal metastases or primary dural metastases.
• Patients who are poor medical risks because of nonmalignant systemic disease, as well as those with acute infection requiring treatment with intravenous antibiotics.
• Patients whose psychiatric condition would, in the judgment of the principal investigator, make it unlikely that they could adhere to the requirements of the protocol.