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Melanoma (Skin)Phase 3NCT00006249

Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma

A Phase 3 study testing pegylated interferon alfa and adjuvant therapy in people with Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 104 sites in 18 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Melanoma (Skin)
What is being tested?
pegylated interferon alfa and adjuvant therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,258 participants
Where
104 sitesin 18 countries
Study dates
Jun 2000to Aug 2003
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed previously resected stage III primary cutaneous melanoma or unknown primary with regional lymph node involvement
  • N1 disease
  • Microscopic, nonpalpable nodal involvement
  • Primary melanoma of any stage with clinically inapparent N1 regional lymph node metastases (T1-4, N1, M0) detected by elective lymph node dissection or sentinel node biopsy
  • N2 disease
  • Palpable nodal involvement with synchronous primary melanoma or apparent nodal disease after prior excision (any pT, N2, M0)
  • Regional lymph node recurrence at any interval after surgery for primary melanoma of any depth (T1-4, rN2, M0)
  • Complete resection of primary melanoma with adequate surgical margins
  • Full lymphadenectomy must be performed within 70 days of study
  • No mucous membrane melanoma or ocular melanoma
  • No evidence of distant or nonregional lymph node metastases or in transit metastases (even if previously resected)
  • No incompletely resected disease due to gross extracapsular extension

PATIENT CHARACTERISTICS:

Age:

  • 18 to 70

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • SGOT and SGPT less than 2 times upper limit of normal
  • No active hepatitis

Renal:

  • Creatinine less than 2.0 mg/dL

Cardiovascular:

  • No severe cardiovascular disease including the following:
  • Arrhythmias requiring chronic treatment
  • Congestive heart failure (New York Heart Association class III or IV)
  • Symptomatic ischemic heart disease

Other:

  • No other prior malignancy within the past 5 years except surgically cured nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • No thyroid dysfunction unresponsive to therapy
  • No uncontrolled diabetes mellitus
  • No active autoimmune disease
  • No active and/or uncontrolled infection
  • No history of neuropsychiatric disorder requiring hospitalization
  • No known active alcohol or drug abuse
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior interferon alfa
  • No prior immunotherapy for melanoma
  • No other concurrent immunologic or biologic therapy
  • No concurrent colony stimulating factors including epoetin alfa and filgrastim (G-CSF)

Chemotherapy:

  • No prior chemotherapy for melanoma
  • No concurrent chemotherapy

Endocrine therapy:

  • No prior hormonal therapy for melanoma
  • No concurrent hormonal therapy
  • No concurrent chronic systemic corticosteroid therapy

Radiotherapy:

  • No prior radiotherapy for melanoma
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from any prior recent surgery

Other:

  • At least 30 days since other prior experimental therapy
  • No other concurrent investigational drugs

Trial locations and contacts

104 sites in 18 countries.

104 sites in 18 countries

United Kingdom26 sites

  • Belfast City Hospital Trust

    Belfast, Northern Ireland, BT9 7AB

  • Selly Oak Hospital at University Hospital NHS Trust

    Birmingham, B29 6JD

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Addenbrooke's NHS Trust

    Cambridge, England, CB2 2QQ

  • Velindre Cancer Center at Velinde Hospital

    Cardiff, Wales, CF4 7XL

  • Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Ninewells Hospital and Medical School

    Dundee, Scotland, DD1 9SY

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Western Infirmary

    Glasgow, Scotland, G11 6NT

  • Royal Surrey County Hospital

    Guildford, England, GU2 5XX

  • Princess Royal Hospital

    Hull, England, HU8 9HE

  • St. James's Hospital

    Leeds, England, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Royal Free Hospital

    London, England, NW3 2QG

  • Guy's and St. Thomas' Hospitals NHS Trust

    London, England, SE1 9RT

  • St. George's Hospital

    London, England, SW17 0QT

  • Royal Marsden NHS Trust

    London, England, SW3 6JJ

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Salisbury District Hospital

    Salisbury, England, SP2 8BJ

  • Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Royal Marsden Hospital

    Sutton, England, SM2 5PT

  • Southend NHS Trust Hospital

    Westcliff-on-Sea, England, SS0 0RY

Other trials in United Kingdom

France23 sites

  • Centre Hospitalier Universitare d'Amens

    Amiens, 80054

  • CHR de Besancon - Hopital Saint-Jacques

    Besançon, 25030

  • Hopital Saint Andre

    Bordeaux, 33075

  • CHU Ambroise Pare

    Boulogne-Billancourt, F-92104

  • CHR de Grenoble - La Tronche

    Grenoble, 38043

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69373

  • Hopital St. Eloi

    Montpellier, 34295

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Hopital L'Archet - 2

    Nice, F-06202

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Universitaire

    Reims, 51092

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • 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

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Germany11 sites

  • Robert Roessle Klinik

    Berlin, D-13122

  • Saint Josef Hospital

    Bochum, D-44791

  • Stadt. Kliniken

    Dortmund, 44123

  • Universitaet Erlangen

    Erlangen, D-91054

  • Georg August Universitaet

    Göttingen, D-37075

  • Haematologisch-Onkologische Praxis Altona

    Hamburg, D-22765

  • Universitaets-Hautklinik Heidelberg

    Heidelberg, D-69115

  • Universitaet Leipzig - Chirurgische Klinik und Poliklinik I

    Leipzig, D-04103

  • Otto - Von - Guericke - Universitaet Magdeburg

    Magdeburg, D-39120

  • Klinikum der Stadt Mannheim

    Mannheim, D-68135

  • Universitaet Wuerzburg/Hautkrankheiten

    Würzburg, D-97080

Other trials in Germany

Italy8 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Ospendale S.M. Annunziata-A.S.DI Firenze

    Florence, I-50011

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa (Genova), 16132

  • European Institute of Oncology - Chemo Prevention

    Milan, 20141

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Milano (Milan), 20133

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Naples, 80131

  • Istituto Regina Elena

    Rome, 00161

  • Universita Degli Studi di Torino

    Torino, 10126

Other trials in Italy

Belgium6 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Clinique Notre Dame de Grace

    Gosselies, 6041

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

Australia5 sites

  • Peter MacCallum Cancer Institute

    East Melbourne, Victoria, 8006

  • Austin and Repatriation Medical Centre

    Heidelberg West, Victoria, 3081

  • David Maddison Clincial Sciences

    Newcastle, NSW 2300

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Sir Charles Gairdner Hospital, Perth

    Perth, Western Australia, 6009

Other trials in Australia

Netherlands5 sites

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1007 MB

  • Leiden University Medical Center

    Leiden, 2300 CA

  • University Medical Center Nijmegen

    Nijmegen, NL-6500 HB

  • Erasmus University Medical Center

    Rotterdam, 3075 EA

  • Academisch Ziekenhuis Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Switzerland4 sites

  • Kantonspital Aarau

    Aarau, 5001

  • Inselspital, Bern

    Bern, CH-3010

  • Ratisches Kantons und Regionalspital

    Chur, CH-7000

  • UniversitaetsSpital

    Zurich, CH-8091

Other trials in Switzerland

Israel3 sites

  • Rambam Medical Center

    Haifa, 31096

  • Wolfson Medical Center

    Holon, 58100

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Poland2 sites

  • Great Poland Cancer Center

    Poznan, 61 866

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

    Warsaw, 02-781

Other trials in Poland

Portugal2 sites

  • Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

    Lisbon, 1099-023 Codex

  • Instituto Portugues de Oncologia Centro do Porto, SA

    Porto, 4200

Other trials in Portugal

Spain2 sites

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario

    Zaragoza, 50009

Other trials in Spain

Turkey (Türkiye)2 sites

  • Vakif Gureba Training Hospital

    Istanbul, 34296

  • Ege University Medical School

    Izmir, 35220

Other trials in Turkey (Türkiye)

Bulgaria1 site

  • National Centre of Oncology

    Sofia, 1756

Other trials in Bulgaria

Croatia1 site

  • University Hospital Sestre Milosrdnice

    Zagreb, 10000

Other trials in Croatia

Czechia1 site

  • Charles University Hospital

    Prague (Praha), 128 08

Other trials in Czechia

Estonia1 site

  • North-Estonian Regional Hospital Cancer Centre

    Tallinn, 11619

Other trials in Estonia

Slovenia1 site

  • Institute of Oncology, Ljubljana

    Ljubljana, Sl-1000

Other trials in Slovenia

About this study

Official title: PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial

RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma.

Read the detailed description

OBJECTIVES:

  • Compare the effect of adjuvant therapy with pegylated interferon alfa vs observation, in terms of distant metastases-free survival, in patients with previously resected stage III melanoma.
  • Compare the overall survival in these patients after treatment with pegylated interferon alfa vs observation.
  • Determine the toxicity of pegylated interferon alfa in these patients.
  • Determine the compliance of these patients treated with pegylated interferon alfa.
  • Compare the quality of life in these patients after treatment with pegylated interferon alfa vs observation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of nodal involvement (N1 vs N2), number of positive nodes (1 vs 2-4 vs 5 or more vs not assessed), Breslow primary (T1-2 vs T3 vs T4 vs unknown), ulceration of primary tumor (absent vs present vs unknown), sex, and center. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive pegylated interferon alfa subcutaneously weekly for 5 years.
  • Arm II: Patients undergo observation only. Treatment continues in the absence of distant metastases or unacceptable toxicity.

Quality of life is assessed at baseline, and then at months 3, 12, 24, 36, 48, and 60.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 1,200 patients (600 per treatment arm) will be accrued for this study within 1.5-2 years.

Conditions
Melanoma (Skin)
Being tested
pegylated interferon alfa, adjuvant therapy
Keywords
stage III melanoma
Medical subject headings
Melanoma

What participants receive

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

Study groups in NCT00006249
Study groupRoleWhat they receive
observationNo intervention5 years observation + 5 years follow up
pegylated interferon alfaExperimental5 years pegylated interferon alfa + 5 years follow up
Receives: Biological: pegylated interferon alfa; Procedure: adjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. distant-metastasis free-survival (DMFS)

    distant-metastasis free-survival (DMFS) after randomization

    Measured: from randomization

Secondary outcomes (2)

  1. survival

    duration of survival: time from randomization until death, whatever the cause

    Measured: from randomization till death

  2. toxicity

    toxicity

    Measured: from randomization

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2000
  3. Primary completionAug 2003

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
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006249
Sponsor's protocol ID
EORTC-18991
Other IDs
EORTC-18991
Status last verified
Feb 2015
First submitted
11 Sep 2000
Last updated
10 Feb 2015
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

  • Eggermont AM, Suciu S, Santinami M, et al.: EORTC 18991 phase III trial: Long-term adjuvant pegylated interferon-α2b (PEG-IFN) versus observation in resected stage III melanoma: long-term results at 7.6-years follow-up. [Abstract] J Clin Oncol 29 (Suppl 15): A-8506b, 2011.

  • Bouwhuis MG, Suciu S, Testori A, Kruit WH, Sales F, Patel P, Punt CJ, Santinami M, Spatz A, Ten Hagen TL, Eggermont AM. Phase III trial comparing adjuvant treatment with pegylated interferon Alfa-2b versus observation: prognostic significance of autoantibodies--EORTC 18991. J Clin Oncol. 2010 May 10;28(14):2460-6. doi: 10.1200/JCO.2009.24.6264. Epub 2010 Apr 12.

    PubMed 20385998

  • Eggermont AM, Bouwhuis MG, Kruit WH, Testori A, ten Hagen T, Yver A, Xu C. Serum concentrations of pegylated interferon alpha-2b in patients with resected stage III melanoma receiving adjuvant pegylated interferon alpha-2b in a randomized phase III trial (EORTC 18991). Cancer Chemother Pharmacol. 2010 Mar;65(4):671-7. doi: 10.1007/s00280-009-1072-z. Epub 2009 Jul 21.

    PubMed 19621225

  • Bottomley A, Coens C, Suciu S, Santinami M, Kruit W, Testori A, Marsden J, Punt C, Sales F, Gore M, Mackie R, Kusic Z, Dummer R, Patel P, Schadendorf D, Spatz A, Keilholz U, Eggermont A. Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma: a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2009 Jun 20;27(18):2916-23. doi: 10.1200/JCO.2008.20.2069. Epub 2009 May 11.

    PubMed 19433686

  • Fusi A, Collette S, Busse A, Suciu S, Rietz A, Santinami M, Kruit WH, Testori A, Punt CJ, Dalgleish AG, Spatz A, Eggermont AM, Keilholz U. Circulating melanoma cells and distant metastasis-free survival in stage III melanoma patients with or without adjuvant interferon treatment (EORTC 18991 side study). Eur J Cancer. 2009 Dec;45(18):3189-97. doi: 10.1016/j.ejca.2009.09.004. Epub 2009 Sep 28.

    PubMed 19793643

  • Eggermont AM, Suciu S, Santinami M, Testori A, Kruit WH, Marsden J, Punt CJ, Sales F, Gore M, MacKie R, Kusic Z, Dummer R, Hauschild A, Musat E, Spatz A, Keilholz U; EORTC Melanoma Group. Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial. Lancet. 2008 Jul 12;372(9633):117-126. doi: 10.1016/S0140-6736(08)61033-8.

    PubMed 18620949

  • Eggermont AM, Suciu S, Santinami M, et al.: EORTC 18991: long-term adjuvant pegylated interferon-alpha2b (PEG-IFN) compared to observation in resected stage III melanoma, final results of a randomized phase III trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-8504, 473s, 2007.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pegylated interferon alfa and adjuvant therapy in people with Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 104 sites in 18 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 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United Kingdom, France, Germany, Italy, Belgium and 13 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.

What does the primary outcome measure?

distant-metastasis free-survival (DMFS) (time frame: from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006249, 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 10 Feb 2015.

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