Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma

Inclusion Criteria: * Malignant melanoma advanced or metastatic. * Other than 18 years * Karnofsky index \> 60 % * Life expectancy \> 3 months * ALT/AST \<=2.5 times the upper normal limit * Creatinine clearance \>= 50 ml/min. * Bilirubin \<25 umol/l * Alkaline phosphatase \<= 2.5 time upper normal limit * Normal bone marrow function: Neutrophils \>=1.5 E9/L, platelets \>= 1E11/L, hemoglobin \>= 100 g/l, Normal prothrombin time and thromboplastin time, * HIV negative * Measurable disease * Signed informed consent. Exclusion Criteria: * Geographical, social or psychological conditions that may impair the protocol compliance. * Active infections or other severe medical status. * History of liver disease. * Other or concomitant treatments for melanoma or investigational product. * Previous participation in studies with adenovirus. * Virus diseases diagnosed two weeks before inclusion. * Immunosuppressive concomitant treatments * Concomitant malignant haematological disease. * Patients having family members with immunodeficient status or disease * Patients with Li Fraumeni syndrome or germinal retinoblastoma gene defects.