High-Dose or Low-Dose Interferon Alfa Compared With No Further Therapy Following Surgery in Treating Patients With Stage III Melanoma
NCT ID: NCT00002763
Last Updated: 2011-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1000 participants
INTERVENTIONAL
1996-04-30
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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recombinant interferon alfa
Eligibility Criteria
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Inclusion Criteria
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
16 Years
75 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Principal Investigators
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Alexander M. M. Eggermont, MD, PhD
Role: STUDY_CHAIR
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Locations
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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
Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent (Gent), , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Alexander's University Hospital
Sofia, , Bulgaria
National Centre of Oncology
Sofia, , Bulgaria
University Hospital Sestre Milosrdnice
Zagreb, , Croatia
Estonian Cancer Center
Tallinn, , Estonia
Tampere University Hospital
Tampere, , Finland
Turku University Central Hospital
Turku, , Finland
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
CHU Ambroise Pare
Boulogne-Billancourt, , France
CHRU de Caen
Caen, , France
Centre Leon Berard
Lyon, , France
Centre Antoine Lacassagne
Nice, , France
Hopital L'Archet - 2
Nice, , France
Hopital Bichat-Claude Bernard
Paris, , France
Hopital Saint-Louis
Paris, , France
Hopital Cochin
Paris, , France
Hopital Haut Leveque
Pessac, , 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
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
Centre Hospitalier Regional Metz Thionville
Thionville, , France
Institut Claudius Regaud
Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Institut Gustave Roussy
Villejuif, , France
Universitaetsklinikum Benjamin Franklin
Berlin, , Germany
Robert Roessle Klinik
Berlin, , Germany
Universitaets-Augenklinik - Erlangen
Erlangen, , Germany
Georg August Universitaet
Göttingen, , Germany
Universitats-Krankenhaus Eppendorf
Hamburg, , Germany
Haematologisch-Onkologische Praxis Altona
Hamburg, , Germany
Department of Dematology, Hannover Medical School
Hanover, , Germany
Universitaets-Hautklinik Heidelberg
Heidelberg, , Germany
Universitatsklinik, Saarland
Homburg/Saar, , Germany
III Medizinische Klinik Mannheim
Mannheim, , Germany
Klinikum der Universitat Regensburg
Regensburg, , Germany
Universitatshautklinik Eberhard - Karlsuniversitat Tubingen
Tübingen, , Germany
Department of Dermatology
Ulm, , Germany
Universitaet Wuerzburg/Hautkrankheiten
Würzburg, , Germany
Wolfson Medical Center
Holon, , Israel
Tel-Aviv Medical Center-Ichilov Hospital
Tel Aviv, , Israel
Istituto Europeo Di Oncologia
Milan, , Italy
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Rotterdam Cancer Institute
Rotterdam, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Medical University of Gdansk
Gdansk, , Poland
Maria Sklodowska-Curie M.C.C.I.O. Krakow
Krakow (Cracow), , Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , Poland
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto
Porto, , Portugal
Russian Academy of Medical Sciences Cancer Research Center
Moscow, , Russia
Institute of Oncology and Radiology of Serbia
Belgrade, , Serbia
National Cancer Institute - Bratislava
Bratislava, , Slovakia
Hospital Clinic y Provincial de Barcelona
Barcelona, , Spain
Hospital Clinico Universitario
Zaragoza, , Spain
Huddinge Hospital
Huddinge, , Sweden
Ospedale San Giovanni
Bellinzona, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Ratisches Kantons und Regionalspital
Chur, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Kantonsspital - Saint Gallen
Sankt Gallen, , Switzerland
Universitaetsspital
Zurich, , Switzerland
Cukurova University School of Medicine
Adana, , Turkey (Türkiye)
Vakif Gureba Training Hospital
Istanbul, , Turkey (Türkiye)
Istanbul University-Institute of Oncology
Istanbul, , Turkey (Türkiye)
Cerrahpasa Medical School
Istanbul, , Turkey (Türkiye)
Ege University Medical School
Izmir, , Turkey (Türkiye)
Bristol Oncology Centre
Bristol, England, United Kingdom
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom
St. James's Hospital
Leeds, England, United Kingdom
Royal Marsden NHS Trust
London, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Countries
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References
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Eggermont AM, Suciu S, Testori A, Kruit WH, Marsden J, Punt CJ, Santinami M, Sales F, Schadendorf D, Patel P, Dummer R, Robert C, Keilholz U, Yver A, Spatz A. Ulceration and stage are predictive of interferon efficacy in melanoma: results of the phase III adjuvant trials EORTC 18952 and EORTC 18991. Eur J Cancer. 2012 Jan;48(2):218-25. doi: 10.1016/j.ejca.2011.09.028. Epub 2011 Nov 5.
Bouwhuis MG, Suciu S, Collette S, Aamdal S, Kruit WH, Bastholt L, Stierner U, Sales F, Patel P, Punt CJ, Hernberg M, Spatz A, ten Hagen TL, Hansson J, Eggermont AM; EORTC Melanoma Group and the Nordic Melanoma Group. Autoimmune antibodies and recurrence-free interval in melanoma patients treated with adjuvant interferon. J Natl Cancer Inst. 2009 Jun 16;101(12):869-77. doi: 10.1093/jnci/djp132. Epub 2009 Jun 9.
Eggermont AM, Punt CJ. Does adjuvant systemic therapy with interferon-alpha for stage II-III melanoma prolong survival? Am J Clin Dermatol. 2003;4(8):531-6. doi: 10.2165/00128071-200304080-00002.
Bouwhuis MG, Collette S, Suciu S, de Groot ER, Kruit WH, Ten Hagen TL, Aarden LA, Eggermont AM, Swaak AJ; EORTC Melanoma Group. Changes of ferritin and CRP levels in melanoma patients treated with adjuvant interferon-alpha (EORTC 18952) and prognostic value on treatment outcome. Melanoma Res. 2011 Aug;21(4):344-51. doi: 10.1097/CMR.0b013e328346c17f.
Bouwhuis MG, Suciu S, Kruit W, Sales F, Stoitchkov K, Patel P, Cocquyt V, Thomas J, Lienard D, Eggermont AM, Ghanem G; European Organisation for Research and Treatment of Cancer Melanoma Group. Prognostic value of serial blood S100B determinations in stage IIB-III melanoma patients: a corollary study to EORTC trial 18952. Eur J Cancer. 2011 Feb;47(3):361-8. doi: 10.1016/j.ejca.2010.10.005. Epub 2010 Nov 17.
Bouwhuis M, Suciu S, Kruit W, et al.: Prognostic value of autoantibodies (auto-AB) in melanoma patients (pts) in the EORTC 18952 trial of adjuvant interferon (IFN) compared to observation (obs). [Abstract] J Clin Oncol 25 (Suppl 18): A-8507, 473s, 2007.
Suciu S, Ghanem G, Kruit W, et al.: Serum S-100B protein is a strong independent prognostic marker for distant-metastasis free survival (DMFS) in stage III melanoma patients: an evaluation of the EORTC randomized trial 18952 comparing IFNα versus observation. [Abstract] J Clin Oncol 25 (Suppl 18): A-8518, 476s, 2007.
Eggermont AM, Suciu S, MacKie R, Ruka W, Testori A, Kruit W, Punt CJ, Delauney M, Sales F, Groenewegen G, Ruiter DJ, Jagiello I, Stoitchkov K, Keilholz U, Lienard D; EORTC Melanoma Group. Post-surgery adjuvant therapy with intermediate doses of interferon alfa 2b versus observation in patients with stage IIb/III melanoma (EORTC 18952): randomised controlled trial. Lancet. 2005 Oct 1;366(9492):1189-96. doi: 10.1016/S0140-6736(05)67482-X.
Other Identifiers
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EORTC-18952
Identifier Type: -
Identifier Source: secondary_id
CDR0000064718
Identifier Type: -
Identifier Source: org_study_id