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Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006249
Recruitment Status : Unknown
Verified February 2015 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

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


Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: pegylated interferon alfa Procedure: adjuvant therapy Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial
Study Start Date : June 2000
Actual Primary Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
No Intervention: observation
5 years observation + 5 years follow up
Experimental: pegylated interferon alfa
5 years pegylated interferon alfa + 5 years follow up
Biological: pegylated interferon alfa
Procedure: adjuvant therapy



Primary Outcome Measures :
  1. distant-metastasis free-survival (DMFS) [ Time Frame: from randomization ]
    distant-metastasis free-survival (DMFS) after randomization


Secondary Outcome Measures :
  1. survival [ Time Frame: from randomization till death ]
    duration of survival: time from randomization until death, whatever the cause

  2. toxicity [ Time Frame: from randomization ]
    toxicity


Other Outcome Measures:
  1. quality of life [ Time Frame: from randomization ]
    Quality of life evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006249


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Locations
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Australia, Victoria
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia, 8006
Austin and Repatriation Medical Centre
Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sir Charles Gairdner Hospital, Perth
Perth, Western Australia, Australia, 6009
Australia
David Maddison Clincial Sciences
Newcastle, Australia, NSW 2300
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Hopital Universitaire Erasme
Brussels, Belgium, 1070
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Clinique Notre Dame de Grace
Gosselies, Belgium, 6041
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Bulgaria
National Centre of Oncology
Sofia, Bulgaria, 1756
Croatia
University Hospital Sestre Milosrdnice
Zagreb, Croatia, 10000
Czech Republic
Charles University Hospital
Prague (Praha), Czech Republic, 128 08
Estonia
North-Estonian Regional Hospital Cancer Centre
Tallinn, Estonia, 11619
France
Centre Hospitalier Universitare d'Amens
Amiens, France, 80054
CHR de Besancon - Hopital Saint-Jacques
Besancon, France, 25030
Hopital Saint Andre
Bordeaux, France, 33075
CHU Ambroise Pare
Boulogne Billancourt, France, F-92104
CHR de Grenoble - La Tronche
Grenoble, France, 38043
Centre Hospitalier Regional et Universitaire de Lille
Lille, France, 59037
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Centre Leon Berard
Lyon, France, 69373
Hopital St. Eloi
Montpellier, France, 34295
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Hopital L'Archet - 2
Nice, France, F-06202
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Saint-Louis
Paris, France, 75475
Hopital Haut Leveque
Pessac, France, 33604
Centre Hospitalier Universitaire
Reims, France, 51092
Centre Eugene Marquis
Rennes, France, 35042
Centre Rene Huguenin
Saint Cloud, France, 92211
Centre Hospitalier Regional et Universitaire de Saint-Etienne
Saint Priest en Jarez, France, 42277
Hopitaux Universitaire de Strasbourg
Strasbourg, France, 67091
Centre Hospitalier Regional Metz Thionville
Thionville, France, 57126
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France, 37044
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Robert Roessle Klinik
Berlin, Germany, D-13122
Saint Josef Hospital
Bochum 1, Germany, D-44791
Stadt. Kliniken
Dortmund, Germany, 44123
Universitaet Erlangen
Erlangen, Germany, D-91054
Georg August Universitaet
Goettingen, Germany, D-37075
Haematologisch-Onkologische Praxis Altona
Hamburg, Germany, D-22765
Universitaets-Hautklinik Heidelberg
Heidelberg, Germany, D-69115
Universitaet Leipzig - Chirurgische Klinik und Poliklinik I
Leipzig, Germany, D-04103
Otto - Von - Guericke - Universitaet Magdeburg
Magdeburg, Germany, D-39120
Klinikum der Stadt Mannheim
Mannheim, Germany, D-68135
Universitaet Wuerzburg/Hautkrankheiten
Wuerzburg, Germany, D-97080
Israel
Rambam Medical Center
Haifa, Israel, 31096
Wolfson Medical Center
Holon, Israel, 58100
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Italy
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Ospendale S.M. Annunziata-A.S.DI Firenze
Firenze, Italy, I-50011
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), Italy, 20133
European Institute of Oncology - Chemo Prevention
Milano, Italy, 20141
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
Istituto Regina Elena
Rome, Italy, 00161
Universita Degli Studi di Torino
Torino, Italy, 10126
Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1007 MB
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Erasmus University Medical Center
Rotterdam, Netherlands, 3075 EA
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3584 CX
Poland
Great Poland Cancer Center
Poznan, Poland, 61 866
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
Lisbon, Portugal, 1099-023 Codex
Instituto Portugues de Oncologia Centro do Porto, SA
Porto, Portugal, 4200
Slovenia
Institute of Oncology, Ljubljana
Ljubljana, Slovenia, Sl-1000
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Clinico Universitario
Zaragoza, Spain, 50009
Switzerland
Kantonspital Aarau
Aarau, Switzerland, 5001
Inselspital, Bern
Bern, Switzerland, CH-3010
Ratisches Kantons und Regionalspital
Chur, Switzerland, CH-7000
UniversitaetsSpital
Zurich, Switzerland, CH-8091
Turkey
Vakif Gureba Training Hospital
Istanbul, Turkey, 34296
Ege University Medical School
Izmir, Turkey, 35220
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom, CB2 2QQ
Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Royal Surrey County Hospital
Guildford, England, United Kingdom, GU2 5XX
Princess Royal Hospital
Hull, England, United Kingdom, HU8 9HE
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Royal Free Hospital
London, England, United Kingdom, NW3 2QG
Guy's and St. Thomas' Hospitals NHS Trust
London, England, United Kingdom, SE1 9RT
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, CH63 4JY
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Salisbury District Hospital
Salisbury, England, United Kingdom, SP2 8BJ
Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Southend NHS Trust Hospital
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Belfast City Hospital Trust
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom, DD1 9SY
Western Infirmary
Glasgow, Scotland, United Kingdom, G11 6NT
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, United Kingdom, CF4 7XL
Selly Oak Hospital at University Hospital NHS Trust
Birmingham, United Kingdom, B29 6JD
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Alexander M. M. Eggermont, MD, PhD Daniel Den Hoed Cancer Center at Erasmus Medical Center

Publications of Results:
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.
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.

Other Publications:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00006249     History of Changes
Other Study ID Numbers: EORTC-18991
EORTC-18991
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage III melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferons
Interferon-alpha
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs