A Prospective Randomized Phase III Clinical Trial Assessing the Role of Post-Operative Radiotherapy Plus Adjuvant Interferon Alpha-2b in Patients With Cervical, Axillary, and Inguinal Nodal Metastasis From Cutaneous Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically documented malignant melanoma in node(s) meeting
one or more of the following criteria: 1 or more lymph nodes found to contain metastatic
melanoma with gross evidence of extracapsular nodal extension Nodal recurrence at the site
of previous lymphadenectomy All gross cancer removed with negative margins Prior node
biopsy allowed if complete nodal dissection performed Parotid involvement outside a node
allowed No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 125,000/mm3
Hematocrit at least 33% Hepatic: AST no greater than 2 times upper limit of normal (ULN)
LDH no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Bilirubin
no greater than 2 times ULN If LDH or alkaline phosphatase are above normal, CT or MRI of
liver required Renal: Creatinine no greater than 1.8 mg/dL BUN no greater than 33 mg/dL
Other: Not pregnant or nursing Fertile patients must use effective contraception No other
prior or concurrent malignancies within 2 years, except any carcinoma in situ, lobular
carcinoma of the breast in situ, carcinoma in situ of the cervix, atypical melanocytic
hyperplasia or Clark I melanoma in situ, or basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon Chemotherapy: Not
specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head
and neck, axillary, or inguinal areas Surgery: See Disease Characteristics Recovered from
prior surgery