Vaccine Therapy in Treating Patients With Stage IV Melanoma

INCLUSION CRITERIA - Patient must meet the following during the screening and baseline visits:

The patients or their legally acceptable representative must give signed informed consent for participation in the study before any study procedure is performed.
Patients must be 18 years of age or older at pre-study
Patients must be ambulatory, ECOG performance status of 0 or 1 (Appendix II)
Patients have histologically confirmed diagnosis of Stage IV melanoma according to AJCC/UICC modified system with an expected survival time of more than 3 months
Patients must be positive for HLA-A2 (Patients tested positive within 5 years of pre-study screening do not need to be tested again for HLA-A2)

Patients must agree to use an acceptable method of birth control

intrauterine device
oral hormonal contraception
combination of spermicide and barrier method or
abstinence
Female patients of childbearing potential must have a confirmed negative urine pregnancy test on Day 0

EXCLUSION CRITERIA - Patients meeting any of the following criteria will NOT be eligible for the study:

Patients who have hematological abnormalities as evidenced by:

Neutrophils < 1,500/mm3
Leukocytes < 3,000/mm3
Platelets < 75,000/mm3
Hemoglobin < 9.0 g/dL

Patients who have hepatic disease as evidenced by:

SGOT/SGPT (AST/ALT) > 2.5 x the upper limit of normal (ULN)
alkaline phosphatase > 2.5 x ULN
Bilirubin > 1.5 x ULN
positive for hepatitis B surface antigen
positive for hepatitis C antibody

Patients who have known or suspected renal impairment as evidenced by:

serum creatinine > 1.5 x ULN, and/or
serum urea > 2.6 x ULN
Patients with a history of ocular melanoma
Patients with brain metastases, unless completed resected
Patients with a positive HIV antibody test
Patients with medical, sociological, or psychological impediments that may compromise compliance with the protocol
Patients who are nursing, pregnant or planning to become pregnant within 6 months of treatment completion
Patients who are receiving chemo-, radio- or immunotherapy concurrently or within the preceding four weeks
Patients who are taking drugs that affect immune function such as systemic corticosteroids or immunomodulatory drugs concurrently or within the preceding four weeks
Patients who are receiving any investigational drug concurrently or within the preceding four weeks