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)

Centre Hospitalier Notre Dame - Reine Fabiola; 🇧🇪 Charleroi, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Ghent (Gent), Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Alexander's University Hospital; 🇧🇬 Sofia, Bulgaria

University Hospital Sestre Milosrdnice; 🇭🇷 Zagreb, Croatia

Tel-Aviv Medical Center-Ichilov Hospital; 🇮🇱 Tel-Aviv, Israel

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

Instituto Portugues de Oncologia do Porto; 🇵🇹 Porto, Portugal

Institute of Oncology and Radiology of Serbia; 🇷🇸 Belgrade, Serbia

National Cancer Institute - Bratislava; 🇸🇰 Bratislava, Slovakia

Landeskrankenanstalten - Salzburg; 🇦🇹 Salzburg, Austria

Krankenhaus der Elisabethinen; 🇦🇹 Linz, Austria

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Hospital Clinic y Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

CHU Ambroise Pare; 🇫🇷 Boulogne Billancourt, France

Universitaet Wuerzburg/Hautkrankheiten; 🇩🇪 Wuerzburg, Germany

Universitaets-Augenklinik - Erlangen; 🇩🇪 Erlangen, Germany

Academisch Ziekenhuis der Vrije Universiteit; 🇳🇱 Amsterdam, Netherlands

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Centre Leon Berard; 🇫🇷 Lyon, France

Universitaets-Hautklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Department of Dermatology; 🇩🇪 Ulm, Germany

Institut Bergonie; 🇫🇷 Bordeaux, France

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

Wolfson Medical Center; 🇮🇱 Holon, Israel

Klinikum der Universitat Regensburg; 🇩🇪 Regensburg, Germany

Hopital Cochin; 🇫🇷 Paris, France

Robert Roessle Klinik; 🇩🇪 Berlin, Germany

Universitatshautklinik Eberhard - Karlsuniversitat Tubingen; 🇩🇪 Tubingen, Germany

Universitatsklinik, Saarland; 🇩🇪 Homburg/Saar, Germany

CHRU de Caen; 🇫🇷 Caen, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Hopital L'Archet - 2; 🇫🇷 Nice, France

Georg August Universitaet; 🇩🇪 Goettingen, Germany

III Medizinische Klinik Mannheim; 🇩🇪 Mannheim, Germany

Academisch Ziekenhuis Utrecht; 🇳🇱 Utrecht, Netherlands

Instituto Portugues de Oncologia de Francisco Gentil; 🇵🇹 Lisbon, Portugal

CHU de Bordeaux - Hopital Pellegrin; 🇫🇷 Bordeaux, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Centre Hospitalier Regional et Universitaire de Saint-Etienne; 🇫🇷 Saint Priest en Jarez, France

Hopital Bichat-Claude Bernard; 🇫🇷 Paris, France

Istanbul University-Institute of Oncology; 🇹🇷 Istanbul, Turkey

Hopital Saint-Louis; 🇫🇷 Paris, France

Hopitaux Universitaire de Strasbourg; 🇫🇷 Strasbourg, France

Centre Hospitalier Regional Metz Thionville; 🇫🇷 Thionville, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Istituto Europeo Di Oncologia; 🇮🇹 Milano, Italy

National Centre of Oncology; 🇧🇬 Sofia, Bulgaria

Turku University Central Hospital; 🇫🇮 Turku, Finland

Universitats-Krankenhaus Eppendorf; 🇩🇪 Hamburg, Germany

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

Estonian Cancer Center; 🇪🇪 Tallinn, Estonia

Tampere University Hospital; 🇫🇮 Tampere, Finland

Hopital Haut Leveque; 🇫🇷 Pessac, France

Centre Hospitalier Universitaire Bretonneau de Tours; 🇫🇷 Tours, France

Universitaetsklinikum Benjamin Franklin; 🇩🇪 Berlin, Germany

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Haematologisch-Onkologische Praxis Altona; 🇩🇪 Hamburg, Germany

Department of Dematology, Hannover Medical School; 🇩🇪 Hannover, Germany

Medical University of Gdansk; 🇵🇱 Gdansk, Poland

Maria Sklodowska-Curie M.C.C.I.O. Krakow; 🇵🇱 Krakow (Cracow), Poland

Russian Academy of Medical Sciences Cancer Research Center; 🇷🇺 Moscow, Russian Federation

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology; 🇵🇱 Warsaw, Poland

Ospedale San Giovanni; 🇨🇭 Bellinzona, Switzerland

Hospital Clinico Universitario; 🇪🇸 Zaragoza, Spain

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Huddinge Hospital; 🇸🇪 Huddinge, Sweden

Cukurova University School of Medicine; 🇹🇷 Adana, Turkey

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital - Saint Gallen; 🇨🇭 Saint Gallen, Switzerland

Ratisches Kantons und Regionalspital; 🇨🇭 Chur, Switzerland

Universitaetsspital; 🇨🇭 Zurich, Switzerland

Vakif Gureba Training Hospital; 🇹🇷 Istanbul, Turkey

Ege University Medical School; 🇹🇷 Izmir, Turkey

Cerrahpasa Medical School; 🇹🇷 Istanbul, Turkey

Bristol Oncology Centre; 🇬🇧 Bristol, England, United Kingdom

Derriford Hospital; 🇬🇧 Plymouth, England, United Kingdom

Royal Marsden NHS Trust; 🇬🇧 London, England, United Kingdom

Beatson Oncology Centre; 🇬🇧 Glasgow, Scotland, United Kingdom

Addenbrooke's NHS Trust; 🇬🇧 Cambridge, England, United Kingdom

St. James's Hospital; 🇬🇧 Leeds, England, United Kingdom