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)