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