High-Dose or Low-Dose Interferon Alfa Compared With No Further Therapy Following Surgery in Treating Patients With Stage III Melanoma

Phase 3

• Conditions: Melanoma (Skin)

• Registration Number: NCT00002763
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1996-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-07-16
• Study First Posted: 2004-07-19
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-15
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (86)

Krankenhaus der Elisabethinen; 🇦🇹 Linz, Austria

Landeskrankenanstalten - Salzburg; 🇦🇹 Salzburg, Austria

Institut Jules Bordet; 🇧🇪 Brussels (Bruxelles), Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels (Bruxelles), Belgium

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Centre Hospitalier Notre Dame - Reine Fabiola; 🇧🇪 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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