Boston,
Massachusetts
02215
Purpose:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon
alfa-2b may interfere with the growth of cancer cells. It is not yet known whether giving
radiation therapy with interferon alfa-2b is more effective than giving interferon alfa-2b
alone in treating melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus
interferon alfa-2b with that of interferon alfa-2b alone in treating patients who have
melanoma that has metastasized to lymph nodes in the neck, under the arm, or in the groin.
Study summary:
OBJECTIVES: I. Evaluate the effectiveness of postoperative hypofractionated radiotherapy in
combination with high dose interferon in preventing regional relapse in patients with
malignant melanoma with any number of nodes with clinical extracapsular extension or
previous nodal basin recurrence. II. Evaluate the effectiveness of this therapy in
prolonging relapse free and overall survival in this patient population. III. Evaluate the
toxicity of this therapy in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to prior nodal basin
recurrence, site of disease, and extracapsular extension. Following surgery, patients are
randomized to receive either interferon alfa-2b alone or five treatments of radiotherapy
followed by interferon alfa-2b. Patients receive radiotherapy 2 days a week for 2.5 weeks.
Patients receive interferon alfa-2b IV over 20 minutes daily for 5 days for a total of 28
days, followed by subcutaneous injections 3 times a week for 48 weeks. Patients are followed
every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 167 patients will be accrued for this study within 3 years.
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