Clinical Study of Previously Untreated Patients With Malignant Melanoma

Inclusion Criteria: Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have not undergone prior chemotherapy for the treatment of melanoma (chemotherapy-naïve) Measurable disease according to Response Criteria in Solid Tumours (RECIST) Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status Age 18 years or more Life expectancy > 3 months Signed informed consent Adequate haematological and biological functions: Bone marrow function: Neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin (Hb) ≥ 10 g/dL Hepatic function: AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver metastases, ≤ 5 times institutional ULN. Serum bilirubin and alkaline phosphatase ≤ 1.5 times institutional ULN Renal function: Creatinine ≤ 1.5 times institutional ULN Exclusion Criteria: Known brain metastases Diagnosis of ocular malignant melanoma Radiotherapy to more than 30% of bone marrow Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study Prior immunotherapy and/or chemotherapy for the treatment of melanoma Requirement of concomitant treatment with a non-permitted medication: Alternative drugs High doses of vitamins History of allergic reactions to Ara-C or egg Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled intercurrent illness including ongoing or active infection) Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance Pregnancy, breastfeeding, or absence of adequate contraception for both male and female fertile patients Known positive status for HIV and/or hepatitis B or C Drug and/or alcohol abuse Any reason why, in the Investigator's opinion, the patient should not participate