Viral Therapy in Treating Patients With Metastatic Melanoma

Inclusion Criteria

• Histologically or cytologically confirmed malignant melanoma
• All melanomas, regardless of origin, are allowed
• Metastatic disease
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm by conventional techniques or as ≥ 10 mm by spiral CT scan
• Must have ≥ 1 metastatic lesion that can be safely biopsied
• Must have received ≥ 1 prior treatment for metastatic disease
• Not a candidate for curative surgery for metastatic disease
• No known brain metastases
• Eastern Cooperative Oncology Group performance status 0-2
• Life expectancy > 12 weeks
• Total White Blood Cell (WBC) ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Aspartate Aminotransferase (AST) ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Troponin-T normal
• Left ventricular ejection fraction (LVEF) ≥ 50% by ECHO or MUGA
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Agrees to provide blood and tissue samples for the mandatory translational research component of the study
• Must be able to avoid direct contact with pregnant or nursing women, infants, and immuno compromised individuals during study and for ≥ 3 weeks following the last dose of study agent
• No concurrent uncontrolled illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris, cardiac arrhythmia, or myocardial infarction within the past year
• Psychiatric illness/social situation that would preclude study compliance
• No known HIV positivity
• Patients with a clinical history suggestive of an immuno compromised status are required to undergo HIV testing
• More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered
• More than 2 weeks since prior radiotherapy, immunotherapy, or treatment with small molecule cell cycle inhibitors
• No other concurrent investigational agents
• No other concurrent anticancer therapy