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)