Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma

DISEASE CHARACTERISTICS:

• Histologically confirmed previously resected stage III primary cutaneous melanoma or unknown primary with regional lymph node involvement

  • N1 disease

    • Microscopic, nonpalpable nodal involvement
    • Primary melanoma of any stage with clinically inapparent N1 regional lymph node metastases (T1-4, N1, M0) detected by elective lymph node dissection or sentinel node biopsy

  • N2 disease

    • Palpable nodal involvement with synchronous primary melanoma or apparent nodal disease after prior excision (any pT, N2, M0)
  • Regional lymph node recurrence at any interval after surgery for primary melanoma of any depth (T1-4, rN2, M0)
• Complete resection of primary melanoma with adequate surgical margins
• Full lymphadenectomy must be performed within 70 days of study
• No mucous membrane melanoma or ocular melanoma
• No evidence of distant or nonregional lymph node metastases or in transit metastases (even if previously resected)
• No incompletely resected disease due to gross extracapsular extension

PATIENT CHARACTERISTICS:

Age:

• 18 to 70

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count greater than 100,000/mm^3
• Hemoglobin at least 9 g/dL

Hepatic:

• SGOT and SGPT less than 2 times upper limit of normal
• No active hepatitis

Renal:

• Creatinine less than 2.0 mg/dL

Cardiovascular:

• No severe cardiovascular disease including the following:

  • Arrhythmias requiring chronic treatment
  • Congestive heart failure (New York Heart Association class III or IV)
  • Symptomatic ischemic heart disease

Other:

• No other prior malignancy within the past 5 years except surgically cured nonmelanomatous skin cancer or carcinoma in situ of the cervix
• No thyroid dysfunction unresponsive to therapy
• No uncontrolled diabetes mellitus
• No active autoimmune disease
• No active and/or uncontrolled infection
• No history of neuropsychiatric disorder requiring hospitalization
• No known active alcohol or drug abuse
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior interferon alfa
• No prior immunotherapy for melanoma
• No other concurrent immunologic or biologic therapy
• No concurrent colony stimulating factors including epoetin alfa and filgrastim (G-CSF)

Chemotherapy:

• No prior chemotherapy for melanoma
• No concurrent chemotherapy

Endocrine therapy:

• No prior hormonal therapy for melanoma
• No concurrent hormonal therapy
• No concurrent chronic systemic corticosteroid therapy

Radiotherapy:

• No prior radiotherapy for melanoma
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• Recovered from any prior recent surgery

Other:

• At least 30 days since other prior experimental therapy
• No other concurrent investigational drugs