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

Prior treatment

• 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

Other illness

• 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
• 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)

Lab values

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

Other

• Clinically palpable lymphadenopathy
• Pregnant or nursing

• 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