Sorafenib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Inclusion Criteria:

Histologically or cytologically confirmed unresectable melanoma

Stage III or IV disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan
Disease amenable to biopsy (first 13 patients in each stratum only)

Brain metastases allowed provided the following criteria are met:

Disease has remained radiologically stable for ≥ 6 weeks after completion of whole-brain radiotherapy and remains stable at the time of study entry
No mass effect present by radiology
No requirement for steroid therapy to control symptoms of brain metastases
Performance status - ECOG 0-2
Performance status - Karnofsky 60-100%
At least 3 months
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
No evidence of bleeding diathesis
AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Bilirubin ≤ 2 times ULN
Creatinine ≤ 1.5 times ULN
No uncontrolled hypertension
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No psychiatric illness that would preclude study compliance
No pre-existing non-hematological dysfunction ≥ grade 2
No ongoing or active infection
No history of serious allergic reaction to eggs
Able to swallow pills
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or other non-invasive carcinoma
No other uncontrolled illness
Not specified
No prior systemic chemotherapy for metastatic disease
See Disease Characteristics
See Disease Characteristics
No other concurrent investigational agents
No concurrent therapeutic anticoagulation
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent anticancer therapy