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