Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma

Eligibility Assessment: (The following assessments must be obtained within three weeks prior to randomization into the study) Medical history and physical examination (including EGOG score, evidence of immunosuppression); CT/MRI of the chest, abdomen and pelvis; Clinical examination; CT/MRI of the brain; Complete Blood Count with differential including platelets; Electrolytes (Na, Cl, K, HCO3, Ca, Mg, PO4); Renal function tests (BUN and creatinine); Liver function tests (bilirubin, AST, ALT); Serum pregnancy test for all women of childbearing potential. Inclusion Criteria: Stage IV Melanoma (AJCC); No prior therapy for stage IV melanoma; No prior therapy with interleukin-2 and/or dacarbazine/temozolomide within the past 12 months prior to study entry; Candidate for surgical resection of some/all sites of melanoma and expected to obtain greater tan or equal to 7 grams of viable cancer tissue (in aggregate), which is equivalent to a greater than or equal to 2 cm lesion on CT/MRI or clinical examination; No brain metastases; ECOG score 0 or 1; Adequate cardiac function; Adequate hematopoietic, liver and renal function; Female subjects of child-bearing potential must agree to use contraception during the study Signed written informed consent. Exclusion Criteria: Mucosal or ocular melanomas; Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer; Primary or secondary immunodeficiency, in the opinion of the investigator (including immunosuppressive disease, or use of systemic corticosteroids or other immunosuppressive medications); Prior splenectomy; Uncontrolled infection or other serious medical illnesses; Women who are pregnant or breast-feeding; Subjects participating in any other studies requiring administration of an investigational drug/biologic agent.