Inclusion Criteria:

• Histologically confirmed primary melanoma of cutaneous origin
• Stage II (T3 N0 M0 1.5-4.0mm Breslow depth
• Clinically negative regional lymph node pathologic status unkown OR
• Histologically negative regional lymph nodes
• Stage III (T4 N0 M0)
• Greater than 4.0mm Breslow depth OR
• Stage III (T1-4 N1)
• One lymph node positive microscopically
• Patients must meet at least 1 of the following criteria
• T2b N0 primary melanoma 1.01-2.0mm with ulceration, node negative
• T3a-b N0 primary melanoma 2.01-4.0mm with and without ulceration, node negative
• T4a-b N0 primary melanoma > 4.0mm with and without ulceration, node negative
• T1aN1a-2a (microscopic)-primary melanoma of any thickness with microscopically positive lymph node (any number)
• Note EORTC patients who are node negative T2 or T3 are ineligible
• Patients with positive sentinel node should undergo complete lymphadenectomy of the nodal basin prior to study
• Must complete all primary therapy (wide excision with or without lymphadenectomy) and be randomized in the study within 84 days of wide excision
• No clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
• No clinically palpable lymphadenopathy

Age:

• 18 and over

Performance Status:

• ECOG 0-1

Life expectancy:

• Not specified Hematopoietic
• WBC at least 3,000/mm^3
• Platelet count at least 125,000/mm^3
• Hematocrit at least 30%

Hepatic:

• Bilirubin no greater than 2 times the upper limit of normal (ULN)
• AST, LDH, and Alkaline phosphate no greater than 2 times ULN
• If lactate dehydrogenase or alkaline phosphate is above normal, a contrast enhanced CT scan or MRI of the liver is required to document the absence of tumor

Renal:

• BUN no greater than 33mg/dl OR
• Creatinine no greater than 1.8mg/dl

Cardiovascular:

• No history of active ischemic heart disease
• No cerebrovascular disease
• No congestive heart failure(New York Heart Association class III or IV heart disease)

Exclusion Criteria:

Biologic Therapy:

• No prior immunotherapy including tumor vaccines, interferon, interleukins,levamisole, or other biologic response modifers for melanoma Chemotherapy
• No prior or concurrent chemotherapy Endocrine Therapy
• No concurrent systemic corticosteriods including oral steriods (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steriod-containing inhalers.

Radiotherapy:

• No Prior or concurrent radiotherapy

Surgery:

• See Disease characteristics

Other:

• No other concurrent immunosuppressive medications
• No other history of invasive melanoma
• No autoimmune disorders or conditions of immunosuppression
• No other concurrent or prior malignancies within past 5 years
• Cancer in situ
• Lobular carcinoma in situ of breast
• Carcinoma in situ of the cervix
• Atypical melanocytic hyperplasia or Clark 1 melanoma in situ
• Basal or squamous cell skin cancer
• No evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation
• No other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation.
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study