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

Inclusion Criteria:

   - Histologically confirmed primary melanoma of cutaneous origin

      - Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)

         - Clinically negative regional lymph node pathologic status unknown OR

         - Histologically negative regional lymph nodes

      - Stage III (T4 N0 M0)

         - Greater than 4.0 mm 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 1.01-2.0 mm with ulceration, node negative

      - T3a-b N0 - primary melanoma 2.01-4.0 mm with and without ulceration, node
      negative

      - T4a-b N0 - primary melanoma > 4.0 mm with or without ulceration, node negative

      - T1a N1a-2a (microscopic) - primary melanoma of any thickness with microscopically
      positive lymph node (any number)

   - Patients with a 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 this study within 84 days of wide excision

   - Must have undergone an adequate wide excision of the primary lesion

   - Age 18 and over (For ECOG patients only, patients must be >=10 years)

   - Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1

   - Adequate hematopoietic, hepatic, and renal function based on the following tests:

      - White blood cell (WBC) cout at least 3,000/mm^3

      - Platelet count at least 125,000/mm^3

      - Hematocrit at least 30%

      - Bilirubin no greater than 2 times upper limit of normal (ULN)

      - Aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and alkaline
      phosphatase no greater than 2 times ULN

      - If lactate dehydrogenase or alkaline phosphatase is above normal, a
      contrast-enhanced computed tomography (CT) scan or Magnetic resonance imaging
      (MRI) of the liver is required to document the absence of tumor

      - Blood urea nitrogen (BUN) no greater than 33 mg/dL OR Creatinine no greater than
      1.8 mg/dL

   - No other concurrent or prior malignancies within the past 5 years except:

      - Cancer in situ

      - Lobular carcinoma in situ of the breast

      - Carcinoma in situ of the cervix

      - Atypical melanocytic hyperplasia or Clark 1 melanoma in situ

      - Basal or squamous cell skin cancer

   - Negative pregnancy test

   - Fertile patients must use effective contraception during and for 6 months after study

Exclusion Criteria:

   - Clinical, radiological/laboratory, or pathological evidence of incompletely resected
   melanoma or any distant metastatic disease

   - Clinically palpable lymphadenopathy

   - Evidence of organic brain syndrome or significant impairment of basal cognitive
   function or any psychiatric disorder that would preclude study participation

   - Other significant medical or surgical condition, or any medication or treatment
   regimens, that would interfere with study participation

   - Pregnant or nursing

   - Other history of invasive melanoma

   - Autoimmune disorders or conditions of immunosuppression

   - History of active ischemic heart disease

   - Cerebrovascular disease

   - Congestive heart failure (New York Heart Association class III or IV heart disease)

   - Prior or concurrent chemotherapy

   - Prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or
   other biologic response modifiers for melanoma

   - Concurrent systemic corticosteroids including oral steroids (i.e., prednisone,
   dexamethasone), topical steroid creams or ointments, or any steroid-containing
   inhalers

   - Prior or concurrent radiotherapy

   - Other concurrent immunosuppressive medications