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:

1. Neutrophils ≥ 1.5 x 10^9/L

2. Platelets ≥ 100 x 10^9/L

3. Hemoglobin (Hb) ≥ 10 g/dL

- Hepatic function:

1. AST/ALT ≤ 2.5 times institutional upper limit of normal (ULN). If liver
metastases, ≤ 5 times institutional ULN.

2. 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