Inclusion Criteria:

- Have read and signed the informed consent form

- 18 years <=Age<= 75 years

- Adequate contraception practice (fertile female patient)

- Confirmed diagnosis of metastatic melanoma (stage IV) with unresectable metastases
and >= 1 measurable lesion

- Adequate renal function as demonstrated by serum creatinine level < 1.5 mg/deciliter
(dl)

- Absolute Neutrophil Count (ANC) >= 1.5 x 10000000000/L ; platelets >= 100 x
10000000000/Liter (L)

- Good performance status: PS <= 1 (ZUBROD-ECOG-WHO scale)

- At least 12 week life expectancy

Exclusion Criteria:

- Clinical diagnosis of autoimmune disease

- Transplant recipient

- Pregnancy documented by a urine pregnancy test or lactation

- Previous treatment with thymosin alpha 1

- Previous treatment with chemotherapy

- Presence of Central Nervous System (CNS) metastases

- Concomitant or prior history of malignancy other than melanoma

- Participation in another investigational trial within 30 days of study entry

- Active infectious process that is not of self-limiting nature