Active Specific Intranodal Immunotherapy of Recombinant Vaccinia Virus in Locally Advanced to Metastatic Melanoma

Inclusion Criteria: Patients older than 18 years Histologically proven melanoma in AJCC stages IIb to IV Resected, recurrent or disseminated disease HLA-A2.1 MHC phenotype Karnofsky performance status equal or higher than 70% Exclusion Criteria: Patients younger than 18 years Pregnancy or inability to perform anticonception MHC phenotype other than HLA-A2.1 Other concurrent malignant disease Estimated life expectancy of less than 6 months Allergic skin diseases, including eczema, psoriasis and neurodermitis Fever or active infection of the respiratory system Concurrent severe cardiac or pulmonary disease (New York Heart Association [NYHA] III and IV) Significant impairment of liver or kidney function (bilirubin > 30umol/l, GOT >2.5xN, GPT >2.5xN, alkaline phosphatase >2.5xN, creatinine >1.5xN adapted to the age) Impairment of the immune system (leucocyte counts <3000/mm3 or granulocytes counts <1500/mm3) Concurrent immunosuppressive therapy Preexisting severe anemia (hemoglobin lower than 80 g/l) Preexisting thrombocytopenia (platelet counts lower than 75,000/ul) Ongoing chemotherapy or chemotherapy completed less than 6 weeks before enrollment in the trial Any medical or psychiatric condition which, in the opinion of the treating physician or principal investigator, would unacceptably reduce the safety of the proposed treatment, would impair the delivery of treatment, or would preclude obtaining voluntary informed consent Patients receiving any other concurrent investigational treatment, or any other concurrent treatment for their cancer Patients who cannot avoid close contact with children less than 3 years of age or with immunocompromised household members