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

About this trial
This is an interventional treatment trial for Stage III Melanoma
Eligibility Criteria
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
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.