RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically. PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.
OBJECTIVES: Primary Objective: * Compare the effect of high-dose interferon alfa-2b treatment on the relapse-free survival of patients with stage II or III resected malignant melanoma. Secondary Objectives: * Compare the effect of this treatment regimen on overall survival of these patients. * Assess the toxicity of this treatment in these patients. * Compare the effect of treatment on quality of life. OUTLINE: This is a randomized study. Patients are stratified by pathologic lymph node status (known vs unknown),lymph node staging procedures(sentinel lymph node procedure vs. elective lymph node dissection vs. no lymphadenectomy), Breslow depth (\<= 1.0 mm vs. 1.01-2.0 mm vs. 2.01-4.0 mm vs \> 4.0 mm), ulceration of the primary lesion (yes vs. no vs. unknown), and disease stage (lymph node positive \[N1, N2a\] vs. lymph node negative \[N0\]). Patients are randomized into one of two treatment arms in a 1:1 ratio. * Arm I (observation): Patients undergo observation for 4 weeks. * Arm II (Interferon Alfa-2b): Patients receive high-dose interferon alfa-2b intravenously (IV) over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity. Quality of life is assessed before treatment, at day 22, every 3 months for 2 years, and then every 6 months for 3 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter until 15 years after randomization. PROJECTED ACCRUAL: A total of 1,420 patients will be accrued for this study over 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
Given IV
Patients undergo observation for 4 weeks.
5-year Relapse-free Survival Rate
Relapse-free survival (RFS) was defined as time from randomization to disease relapse or death from any cause, whichever occurred first. Patients without disease relapse were censored at last disease assessment date known of free of relapse. Kaplan-Meier method was used to estimate 5-year RFS rate in the intent-to-treat (ITT) patients.
Time frame: assessed every 3 months for 2 years, every 6 months for 3 years
5-year Overall Survival Rate
Overall survival (OS) was defined as time from randomization to death from any cause. Patients still alive were censored at last known alive date. Kaplan-Meier method was used to estimate 5-year OS rate in the ITT patients.
Time frame: assessed every 3 months for 2 years, every 6 months for 3 years
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NONE
Enrollment
1,150
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