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

DISEASE CHARACTERISTICS:

• 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:

  • T_2b N_0 - primary melanoma 1.01-2.0 mm with ulceration, node negative
  • T_3a-b N_0 - primary melanoma 2.01-4.0 mm with and without ulceration, node negative
  • T_4a-b N_0 - primary melanoma > 4.0 mm with or without ulceration, node negative
  • T_1-a N_1a-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
• No clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
• No clinically palpable lymphadenopathy

PATIENT CHARACTERISTICS:

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 upper limit of normal (ULN)
• AST, LDH, and alkaline phosphatase no greater than 2 times ULN
• If lactate dehydrogenase or alkaline phosphatase 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 33 mg/dL OR
• Creatinine no greater than 1.8 mg/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)

Other:

• No other history of invasive melanoma
• No autoimmune disorders or conditions of immunosuppression

• 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
• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma

Chemotherapy:

• No prior or concurrent chemotherapy

Endocrine therapy:

• No concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers

Radiotherapy:

• No prior or concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No other concurrent immunosuppressive medications