A Study of Recombinant Vaccinia Virus to Treat Malignant Melanoma

Inclusion Criteria: * Histologically-confirmed, Stage 3 or Stage 4 malignant melanoma * At least one tumor mass measurable by CT/MRI and/or physical examination that can be injected by direct visualization or by ultrasound-guidance * Anticipated survival of at least 16 weeks * Cancer is not surgically resectable for cure * KPS score of ≥ 70 (refer to APPENDIX E: KARNOFSKY PERFORMANCE STATUS (KPS)) * Age ≥18 years * Men and women of reproductive potential must be willing to follow accepted birth control methods during treatment and for 3 months after the last treatment with JX-594 * The ability to understand and willingness to sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form * Able to comply with study procedures and follow-up examinations * Adequate liver function: Total bilirubin ≤ 2.0 x ULN; AST, ALT ≤ 2.0 x ULN * Adequate bone marrow function: WBC \> 3,500 cells/mm3 and \< 50,000 cells/mm3; ANC \> 1,500 cells/mm3; Hemoglobin \> 10 g/dL; Platelet count \> 125,000 plts/mm3 * Acceptable coagulation status: INR \< (ULN + 10%) * Acceptable kidney function: Serum creatinine \< 2.0 mg/dL Exclusion Criteria: * Target tumor(s) adherent to and/or invading a major vascular structure (e.g. carotid artery) * Pregnant or nursing an infant * Known infection with HIV * Systemic corticosteroid or other immunosuppressive medication use within 4 weeks of first treatment with JX-594 * Clinically significant active infection …