Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma

February 9, 2015 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1258

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

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

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Procedure: adjuvant therapy
Biological: pegylated interferon alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
distant-metastasis free-survival (DMFS)
Time Frame: from randomization
distant-metastasis free-survival (DMFS) after randomization
from randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: from randomization till death
duration of survival: time from randomization until death, whatever the cause
from randomization till death
toxicity
Time Frame: from randomization
toxicity
from randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: from randomization
Quality of life evaluation
from randomization

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

June 1, 2000

Primary Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-18991

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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