RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not known whether giving high-dose or low-dose interferon alfa is more effective than no further therapy in treating patients with stage III melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of high- or low-dose interferon alfa with that of no further therapy following surgery in treating patients who have stage III melanoma.
OBJECTIVES: I. Evaluate the time to distant metastasis, death due to melanoma, and overall survival in patients with high-risk stage III melanoma treated with 10 MU of interferon alfa (IFN-A) for 4 weeks followed by 1 year of IFN-A at 10 MU three times per week vs. 2 years of IFN-A at 5 MU three times per week vs. observation alone. II. Assess the toxicity associated with IFN-A. III. Compare the quality of life, costs, and compliance associated with each treatment regimen. OUTLINE: Randomized study. Following definitive surgical resection, patients are randomly assigned in a 2:2:1 ratio to Arms A, B, and C, respectively. Arm A: Biological Response Modifier Therapy. Interferon alfa-2b (Schering), IFN-A, NSC-377523. Higher dose. Arm B: Biological Response Modifier Therapy. IFN-A. Lower dose. Arm C: Control. Observation. PROJECTED ACCRUAL: A total of 1,000 patients will be entered over approximately 4 years in this multicenter study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
1,000
Krankenhaus der Elisabethinen
Linz, Austria
Landeskrankenanstalten - Salzburg
Salzburg, Austria
Hopital Universitaire Erasme
Brussels, Belgium
Institut Jules Bordet
Brussels (Bruxelles), Belgium
Cliniques Universitaires Saint-Luc
Brussels (Bruxelles), Belgium
Centre Hospitalier Notre Dame - Reine Fabiola
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Charleroi, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent (Gent), Belgium
U.Z. Gasthuisberg
Leuven, Belgium
Alexander's University Hospital
Sofia, Bulgaria
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