High-Dose Interferon Alfa in Treating Patients With Stage II or StageIII Melanoma

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