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Melanoma (Skin)Phase 3NCT00002763

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

A Phase 3 study testing recombinant interferon alfa in people with Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 86 sites in 21 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Melanoma (Skin)
What is being tested?
recombinant interferon alfa
How many people
1,000 participants
Where
86 sitesin 21 countries
Study dates
Apr 1996to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

86 sites in 21 countries.

86 sites in 21 countries

France19 sites

  • CHU de Bordeaux - Hopital Pellegrin

    Bordeaux, 33076

  • Institut Bergonie

    Bordeaux, 33076

  • CHU Ambroise Pare

    Boulogne-Billancourt, F-92104

  • CHRU de Caen

    Caen, 14033

  • Centre Leon Berard

    Lyon, 69373

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital L'Archet - 2

    Nice, F-06202

  • Hopital Bichat-Claude Bernard

    Paris, 75018

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Cochin

    Paris, 75674

  • Hopital Haut Leveque

    Pessac, 33604

  • Centre Eugene Marquis

    Rennes, 35062

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Centre Hospitalier Regional et Universitaire de Saint-Etienne

    Saint-Priest-en-Jarez, 42277

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67091

  • Centre Hospitalier Regional Metz Thionville

    Thionville, 57126

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Germany14 sites

  • Universitaetsklinikum Benjamin Franklin

    Berlin, D-12200

  • Robert Roessle Klinik

    Berlin, D-13122

  • Universitaets-Augenklinik - Erlangen

    Erlangen, D-91054

  • Georg August Universitaet

    Göttingen, D-37075

  • Universitats-Krankenhaus Eppendorf

    Hamburg, D-20246

  • Haematologisch-Onkologische Praxis Altona

    Hamburg, D-22765

  • Department of Dematology, Hannover Medical School

    Hanover, D-30449

  • Universitaets-Hautklinik Heidelberg

    Heidelberg, D-69115

  • Universitatsklinik, Saarland

    Homburg/Saar, D-66421

  • III Medizinische Klinik Mannheim

    Mannheim, D-68305

  • Klinikum der Universitat Regensburg

    Regensburg, DOH-9-3053

  • Universitatshautklinik Eberhard - Karlsuniversitat Tubingen

    Tübingen, DOH-7-2076

  • Department of Dermatology

    Ulm, DOH-8-9081

  • Universitaet Wuerzburg/Hautkrankheiten

    Würzburg, D-97080

Other trials in Germany

Belgium7 sites

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Institut Jules Bordet

    Brussels (Bruxelles), 1000

  • Cliniques Universitaires Saint-Luc

    Brussels (Bruxelles), 1200

  • Centre Hospitalier Notre Dame - Reine Fabiola

    Charleroi, 6000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Universitair Ziekenhuis Gent

    Ghent (Gent), B-9000

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

Netherlands7 sites

  • Academisch Ziekenhuis der Vrije Universiteit

    Amsterdam, 1007 MB

  • Antoni van Leeuwenhoekhuis

    Amsterdam, 1066 CX

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 EZ

  • Leiden University Medical Center

    Leiden, 2300 ZA

  • University Medical Center Nijmegen

    Nijmegen, NL-6252 HB

  • Rotterdam Cancer Institute

    Rotterdam, 3075 EA

  • Academisch Ziekenhuis Utrecht

    Utrecht, 3508 GA

Other trials in Netherlands

Switzerland6 sites

  • Ospedale San Giovanni

    Bellinzona, CH-6500

  • Inselspital, Bern

    Bern, CH-3010

  • Ratisches Kantons und Regionalspital

    Chur, CH-7000

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital - Saint Gallen

    Sankt Gallen, CH-9007

  • Universitaetsspital

    Zurich, CH-8091

Other trials in Switzerland

United Kingdom6 sites

  • Bristol Oncology Centre

    Bristol, England, BS2 8ED

  • Addenbrooke's NHS Trust

    Cambridge, England, CB2 2QQ

  • Beatson Oncology Centre

    Glasgow, Scotland, G11 6NT

  • St. James's Hospital

    Leeds, England, LS9 7TF

  • Royal Marsden NHS Trust

    London, England, SW3 6JJ

  • Derriford Hospital

    Plymouth, England, PL6 8DH

Other trials in United Kingdom

Turkey (Türkiye)5 sites

  • Cukurova University School of Medicine

    Adana, 01330

  • Vakif Gureba Training Hospital

    Istanbul, 34296

  • Istanbul University-Institute of Oncology

    Istanbul, 34390

  • Cerrahpasa Medical School

    Istanbul

  • Ege University Medical School

    Izmir, 35220

Other trials in Turkey (Türkiye)

Poland3 sites

  • Medical University of Gdansk

    Gdansk, 80-211

  • Maria Sklodowska-Curie M.C.C.I.O. Krakow

    Krakow (Cracow), 31-115

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02-781

Other trials in Poland

Austria2 sites

  • Krankenhaus der Elisabethinen

    Linz, 4020

  • Landeskrankenanstalten - Salzburg

    Salzburg, 5020

Other trials in Austria

Bulgaria2 sites

  • Alexander's University Hospital

    Sofia, 1431

  • National Centre of Oncology

    Sofia, 1756

Other trials in Bulgaria

Finland2 sites

  • Tampere University Hospital

    Tampere, 33521

  • Turku University Central Hospital

    Turku, FIN-2-0521

Other trials in Finland

Israel2 sites

  • Wolfson Medical Center

    Holon, 58100

  • Tel-Aviv Medical Center-Ichilov Hospital

    Tel Aviv, 62995

Other trials in Israel

Portugal2 sites

  • Instituto Portugues de Oncologia de Francisco Gentil

    Lisbon, 1093

  • Instituto Portugues de Oncologia do Porto

    Porto, 4200

Other trials in Portugal

Spain2 sites

  • Hospital Clinic y Provincial de Barcelona

    Barcelona, 08036

  • Hospital Clinico Universitario

    Zaragoza, 50009

Other trials in Spain

Croatia1 site

  • University Hospital Sestre Milosrdnice

    Zagreb, 10000

Other trials in Croatia

Estonia1 site

  • Estonian Cancer Center

    Tallinn, 11619

Other trials in Estonia

Italy1 site

  • Istituto Europeo Di Oncologia

    Milan, 20141

Other trials in Italy

Russia1 site

  • Russian Academy of Medical Sciences Cancer Research Center

    Moscow, 115478

Other trials in Russia

Serbia1 site

  • Institute of Oncology and Radiology of Serbia

    Belgrade, 11000

Other trials in Serbia

Slovakia1 site

  • National Cancer Institute - Bratislava

    Bratislava, 833 10

Other trials in Slovakia

Sweden1 site

  • Huddinge Hospital

    Huddinge, S-141 86

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Conditions
Melanoma (Skin)
Being tested
recombinant interferon alfa
Keywords
stage III melanoma, recurrent melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interferon alfaBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2004 (estimated)
  2. Study startApr 1996

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002763
Sponsor's protocol ID
CDR0000064718
Other IDs
EORTC-18952
Status last verified
Nov 2011
First submitted
1 Nov 1999
Last updated
16 Nov 2011
Results posted
No

Publications

  • 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.

    PubMed 22056637

  • 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.

    PubMed 19509353

  • 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.

    PubMed 12862495

  • 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.

    PubMed 21546857

  • 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.

    PubMed 21087856

  • 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.

    PubMed 16198768

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing recombinant interferon alfa in people with Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 86 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in France, Germany, Belgium, Netherlands, Switzerland and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002763, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.

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