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

You may be eligible if

• 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)