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

November 15, 2011 updated by: European Organisation for Research and Treatment of Cancer - EORTC

POST-OPERATIVE ADJUVANT INTERFERON-ALFA-2B (INTRON-A) TREATMENT AFTER RESECTION OF THICK PRIMARY MELANOMA AND/OR REGIONAL LYMPHNODE METASTASES 'INTERMEDIATE-HIGH DOSE' VS INTERMEDIATE-LOW DOSE' IFN-ALFA VS OBSERVATION: A 3-ARM MULTICENTER RANDOMIZED PHASE III TRIAL

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Krankenhaus der Elisabethinen
      • Salzburg, Austria, 5020
        • Landeskrankenanstalten - Salzburg
  • Belgium
      • Brussels, Belgium, 1070
        • Hopital Universitaire Erasme
      • Brussels (Bruxelles), Belgium, 1000
        • Institut Jules Bordet
      • Brussels (Bruxelles), Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Charleroi, Belgium, 6000
        • Centre Hospitalier Notre Dame - Reine Fabiola
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Ghent (Gent), Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Bulgaria
      • Sofia, Bulgaria, 1756
        • National Centre of Oncology
      • Sofia, Bulgaria, 1431
        • Alexander's University Hospital
  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Sestre Milosrdnice
  • Estonia
      • Tallinn, Estonia, 11619
        • Estonian Cancer Center
  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital
      • Turku, Finland, FIN-2-0521
        • Turku University Central Hospital
  • France
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Bordeaux, France, 33076
        • CHU de Bordeaux - Hôpital Pellegrin
      • Boulogne Billancourt, France, F-92104
        • CHU Ambroise Pare
      • Caen, France, 14033
        • CHRU de Caen
      • Lyon, France, 69373
        • Centre léon bérard
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nice, France, F-06202
        • Hopital L'Archet - 2
      • Paris, France, 75674
        • Hopital Cochin
      • Paris, France, 75018
        • Hopital Bichat-Claude Bernard
      • Paris, France, 75475
        • Hopital Saint-Louis
      • Pessac, France, 33604
        • Hopital Haut Lévêque
      • Rennes, France, 35062
        • Centre Eugène Marquis
      • Saint Cloud, France, 92210
        • Centre Rene Huguenin
      • Saint Priest en Jarez, France, 42277
        • Centre Hospitalier Regional et Universitaire de Saint-Etienne
      • Strasbourg, France, 67091
        • Hopitaux Universitaire de Strasbourg
      • Thionville, France, 57126
        • Centre Hospitalier Regional Metz Thionville
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Tours, France, 37044
        • Centre Hospitalier Universitaire Bretonneau de Tours
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, D-12200
        • Universitaetsklinikum Benjamin Franklin
      • Berlin, Germany, D-13122
        • Robert Roessle Klinik
      • Erlangen, Germany, D-91054
        • Universitaets-Augenklinik - Erlangen
      • Goettingen, Germany, D-37075
        • Georg August Universitaet
      • Hamburg, Germany, D-22765
        • Haematologisch-Onkologische Praxis Altona
      • Hamburg, Germany, D-20246
        • Universitäts-Krankenhaus Eppendorf
      • Hannover, Germany, D-30449
        • Department of Dematology, Hannover Medical School
      • Heidelberg, Germany, D-69115
        • Universitaets-Hautklinik Heidelberg
      • Homburg/Saar, Germany, D-66421
        • Universitatsklinik, Saarland
      • Mannheim, Germany, D-68305
        • III Medizinische Klinik Mannheim
      • Regensburg, Germany, DOH-9-3053
        • Klinikum der Universität Regensburg
      • Tubingen, Germany, DOH-7-2076
        • Universitatshautklinik Eberhard - Karlsuniversitat Tubingen
      • Ulm, Germany, DOH-8-9081
        • Department of Dermatology
      • Wuerzburg, Germany, D-97080
        • Universitaet Wuerzburg/Hautkrankheiten
  • Israel
      • Holon, Israel, 58100
        • Wolfson Medical Center
      • Tel-Aviv, Israel, 62995
        • Tel-Aviv Medical Center-Ichilov Hospital
  • Italy
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoekhuis
      • Amsterdam, Netherlands, 1007 MB
        • Academisch Ziekenhuis der Vrije Universiteit
      • Groningen, Netherlands, 9713 EZ
        • Academisch Ziekenhuis Groningen
      • Leiden, Netherlands, 2300 ZA
        • Leiden University Medical Center
      • Nijmegen, Netherlands, NL-6252 HB
        • University Medical Center Nijmegen
      • Rotterdam, Netherlands, 3075 EA
        • Rotterdam Cancer Institute
      • Utrecht, Netherlands, 3508 GA
        • Academisch Ziekenhuis Utrecht
  • Poland
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk
      • Krakow (Cracow), Poland, 31-115
        • Maria Sklodowska-Curie M.C.C.I.O. Krakow
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Portugal
      • Lisbon, Portugal, 1093
        • Instituto Portugues de Oncologia de Francisco Gentil
      • Porto, Portugal, 4200
        • Instituto Portugues de Oncologia do Porto
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Russian Academy of Medical Sciences Cancer Research Center
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Oncology and Radiology of Serbia
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • National Cancer Institute - Bratislava
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic y Provincial de Barcelona
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario
  • Sweden
      • Huddinge, Sweden, S-141 86
        • Huddinge Hospital
  • Switzerland
      • Bellinzona, Switzerland, CH-6500
        • Ospedale San Giovanni
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Chur, Switzerland, CH-7000
        • Ratisches Kantons und Regionalspital
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Saint Gallen, Switzerland, CH-9007
        • Kantonsspital - Saint Gallen
      • Zurich, Switzerland, CH-8091
        • UniversitaetsSpital
  • Turkey
      • Adana, Turkey, 01330
        • Cukurova University School of Medicine
      • Istanbul, Turkey, 34296
        • Vakif Gureba Training Hospital
      • Istanbul, Turkey, 34390
        • Istanbul University-Institute of Oncology
      • Istanbul, Turkey
        • Cerrahpasa Medical School
      • Izmir, Turkey, 35220
        • Ege University Medical School
  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Oncology Centre
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's NHS Trust
      • Leeds, England, United Kingdom, LS9 7TF
        • St. James's Hospital
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Trust
      • Plymouth, England, United Kingdom, PL6 8DH
        • Derriford Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Beatson Oncology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Cutaneous melanoma in one of the following categories: T4, N0, M0 Deep primary tumor with Breslow depth greater than 4.0 cm Tx, N1, M0 Primary tumor with regional lymph node metastases found at lymphadenectomy but clinically undetectable Tx, N2, M0 Clinically apparent regional lymph node metastases (synchronous or metachronous) confirmed by lymphadenectomy Definitive surgical resection and lymphadenectomy with pathologically confirmed adequate surgical margins required Minimum 2 cm margin for primary lesions with Breslow depth greater than 2 mm Distal interphalangeal amputation required for subungual melanomas No primary melanoma originating apart from the skin No multiple in transit metastases in an extremity No lymph node involvement outside the operative area resected by radical neck, axillary lymph node, or ilioinguinal dissection

PATIENT CHARACTERISTICS: Age: 16 to 75 Performance status: ECOG 0 or 1 Hematopoietic: WBC at least 4,000 Platelets at least 125,000 Hemoglobin at least 9.8 g/dL (6.1 mmol/L) Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2 times normal Renal: Creatinine no greater than 1.6 mg/dL (140 micromoles/L) Cardiovascular: No ventricular or supraventricular arrhythmia requiring treatment No congestive heart failure (NYHA class 3/4 status) Other: No uncontrolled infection No requirement for ongoing steroids, NSAIDs, or other immunomodulators No organic brain syndrome or significant impairment of basal cognitive function No psychiatric disorder that would preclude study participation or would be exacerbated by study therapy (e.g., depression) No second malignancy except: In situ cervical cancer Nonmelanomatous skin cancer No pregnant or nursing women

PRIOR CONCURRENT THERAPY: No prior treatment on this protocol for patients with recurrent melanoma at regional lymph nodes No preoperative infusion or perfusion therapy Biologic therapy: No prior adjuvant immunotherapy Chemotherapy: No prior adjuvant systemic chemotherapy No prior anthracyclines Endocrine therapy: Not specified Radiotherapy: No prior adjuvant radiotherapy Surgery: See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Alexander M. M. Eggermont, MD, PhD, Daniel Den Hoed Cancer Center at Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1996

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 16, 2004

First Posted (Estimate)

July 19, 2004

Study Record Updates

Last Update Posted (Estimate)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000064718
  • EORTC-18952

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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