Phase I Clinical Trial of Endovenous Administration of Conditionally Replicative Adenovirus ICOVIR-5 in Patients With Locally Advanced or Metastatic Melanoma
- 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.
- Geographical, social or psychological conditions that may impair the protocol
- 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.