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