Phase II Study of Gamma Knife Radiosurgery and Temozolomide for Brain Metastases

Inclusion Criteria

• All subjects must have history of histologically confirmed malignancy. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
• Newly diagnosed brain metastases (four or fewer by thin slice post-contrast MRI).
• ECOG performance status of less than or equal to 2 for patients with no prior chemotherapy, and less than or equal to 1 for patients with prior chemotherapy.
• Age greater than 18
• Life expectancy greater than 12 weeks
• Subjects given written informed consent
• Adequate hematologic, renal and liver function as demonstrated by laboratory values performed within 14 days, inclusive, prior to administration of study drug:
• Absolute neutrophil count (ANC) >= 1500/mm3
• Platelet count >= 100,000/mm3
• Hemoglobin >= 9 g/dL
• BUN and serum creatinine = 15% of bone marrow and less than 2 weeks prior for radiotherapy to < 15% of bone marrow.
• Insufficient recovery from all active toxicities of prior therapies
• Subjects who are poor medical risks because of non-malignant systemic disease
• Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction).
• Previous or concurrent malignancies at other sites, or treatment for malignancy at the site within 5 years of study start with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
• Known HIV positively or AIDS-related illness.
• Pregnant or nursing women.
• Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
• Men who are not advised to use an effective method of contraception.