Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma

Inclusion Criteria: Histologically or cytologically confirmed metastatic melanoma Clinical evidence of brain metastases At least 1 unidimensionally measurable brain lesion at least 2.0 cm by conventional techniques OR at least 1.0 cm by spiral CT scan or MRI The following lesions are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Lesions situated in a previously irradiated area, unless new growth is documented Performance status - CTC 0-1 Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 AST and ALT no greater than 2.5 times upper limit of normal (ULN) Lactic dehydrogenase no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Creatinine no greater than 2 mg/dL No history of active angina No history of significant ventricular arrhythmia No history of deep vein thrombosis No myocardial infarction within the past 6 months No acute abnormality by EKG No uncontrolled arrhythmia No history of pulmonary embolism Not pregnant or nursing Negative pregnancy test Fertile patients must use 1 highly-effective and 1 additional method of contraception for 28 days before, during, and for 4 weeks after study participation No known HIV disease Thyroid-stimulating hormone normal Serum anticonvulsant levels normal (for patients on anticonvulsants) No frequent vomiting and/or any other medical condition (e.g., partial bowel obstruction) that would preclude oral medication intake No preexisting neuropathy greater than grade 1 No uncontrolled seizures No other concurrent medical condition that would preclude study participation At least 4 weeks since prior cytokines Biologic agents used as adjuvants, vaccines, and cellular therapies do not require a 4-week washout period No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) No more than 1 prior chemotherapy regimen No prior chemotherapy for brain metastases No prior continuous daily temozolomide At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy No concurrent hormonal therapy except steroids and hormones administered for non-disease-related conditions (e.g., insulin for diabetes) or for control of intracranial edema from brain metastases See Disease Characteristics Prior whole brain radiotherapy (WBRT) allowed provided patient has progressive disease in a measurable CNS lesion Prior stereotactic radiotherapy allowed provided patient has progressive disease in a measurable CNS lesion At least 4 weeks since prior WBRT At least 3 weeks since prior stereotactic radiosurgery No concurrent radiotherapy At least 3 weeks since prior surgical resection No concurrent warfarin or heparin products or their derivatives No concurrent antiplatelet therapy (e.g., daily aspirin, ibuprofen, or clopidogrel bisulfate) No concurrent bisphosphonates (e.g., zoledronate)