Adjuvant PEG Intron in Ulcerated Melanoma

February 28, 2019 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus Observation in Patients With an Ulcerated Primary Cutaneous Melanoma With T(2-4)bN0M0: a Randomized Phase III Trial of the EORTC Melanoma Group.

Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk.

The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

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

  • Austria
      • Graz, Austria
        • Medical University of Graz
  • Belgium
      • Brussels, Belgium
        • Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet
      • Ghent, Belgium
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium
        • U.Z. Leuven - Campus Gasthuisberg
  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital
      • Herlev, Denmark
        • Herlev Hospital - University Copenhagen
      • Odense, Denmark
        • Odense University Hospital
  • France
      • Bobigny, France
        • Assistance Publique - Hopitaux de Paris - Hopital Avicenne
      • Bordeaux, France
        • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre (Bordeaux, France
      • Grenoble, France
        • CHU de Grenoble - La Tronche - Hôpital A. Michallon
      • Lille, France
        • CHRU de Lille
      • Lyon, France
        • Centre LEON BERARD
      • Marseille, France
        • Assistance Publique - Hôpitaux de Marseille - Hôpital de La Timone
      • Nice, France
        • CHU de Nice - CHU de Nice - Hopital De L'Archet
      • Paris, France
        • Institut Gustave Roussy
      • Paris, France
        • Assistance Publique - Hopitaux de Paris - CHU Ambroise Pare
      • Paris, France
        • Assitance Publique - Hopitaux de Paris - Hopital Bichat-Claude Bernard
      • Paris, France
        • Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis
      • Pau, France
        • Centre Hospitalier de Pau
      • Reims, France
        • CHU de Reims - Hôpital Robert Debré
      • Salouel, France
        • CHU d'Amiens - CHU Amiens - Hopital Sud
  • Germany
      • Essen, Germany
        • Universitaetsklinikum
      • Heidelberg, Germany
        • Universitaetsklinikum Heidelberg - Hautklinik / Dermatologic Department
      • Heidelburg, Germany
        • Universitaetsklinikum Heidelberg - Hautklinik
      • Kiel, Germany
        • Universitaetsklinikum Schleswig-Holstein
      • Koeln, Germany
        • Universitaetsklinikum Koeln
      • Luebeck, Germany
        • Medizinische Universitaet Zu Luebeck
      • Mainz, Germany
        • Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center
      • Mannheim, Germany
        • Universitaetsmedizin Mannheim
      • Wuerzburg, Germany
        • Universitaetsklinikum Wuerzburg
  • Italy
      • Bari, Italy
        • IRCCS - Istituto Tumori "Giovanni Paolo II"
      • Milan, Italy
        • Istituto Europeo Di Oncologia
      • Napoli, Italy
        • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
      • Roma, Italy
        • Istituto Dermopatico dell'Immacolata
      • Udine, Italy
        • Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine
  • Netherlands
      • Amsterdam, Netherlands
        • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
      • Amsterdam, Netherlands
        • Vrije Universiteit Medisch Centrum
      • Leiden, Netherlands
        • Leiden University Medical Centre
  • Poland
      • Warsaw, Poland
        • Maria Sklodowska-Curie Memorial Cancer Centre
  • Portugal
      • Lisboa, Portugal, 1099-023
        • I.P.O. Francisco Gentil - Centro De Lisboa
      • Lisboa, Portugal
        • I.P.O. Francisco Gentil - Centro De Lisboa
      • Santarem, Portugal
        • Hospital Distrital de Santarém
  • Spain
      • Barcelona, Spain
        • Hospital Clinic Universitari
      • Madrid, Spain
        • Hospital Universitario 12 de octubre
  • Switzerland
      • Zurich, Switzerland
        • UniversitaetsSpital Zurich
  • United Kingdom
      • Bebington, United Kingdom
        • Clatterbridge Centre for Oncology NHS Trust - Clatterbridge Cancer Centre NHS Foundation Trust
      • Birmingham, United Kingdom
        • University Hospitals Birmingham NHS Foundation Trust (UHB) - Queen Elisabeth Medical Centre
      • Broomfield, United Kingdom
        • Mid Essex Hospitals - Broomfield Hospital
      • Cambridge, United Kingdom
        • Cambridge University Hospital NHS - Addenbrookes Hospital
      • Cheltenham, United Kingdom
        • Cheltenham General Hospital
      • Glasgow, United Kingdom
        • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
      • London, United Kingdom
        • St George's Hospital NHS Trust (6961)
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
      • Norwich, United Kingdom
        • Norfolk and Norwich Hospital
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust - City Hospital
      • Southampton, United Kingdom
        • University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
      • St Helens, United Kingdom
        • St Helens and Knowsley Teaching Hospitals

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

Inclusion Criteria:

  • Subjects must be between 18-70 years old.
  • Subjects must have histologically documented ulcerated primary cutaneous melanomas with T(2-4)b N0M0.

Adequate resection of ulcerated primary cutaneous melanoma. 1 to 2 cm normal tissue excision margins according to Breslow thickness are recommended. In the head and neck areas and in case of locations distally on extremities, narrower margins are acceptable as long as they are radical (see Appendix F). Subjects must have recovered from the effects of recent surgery.

  • SNB must occur within 12 weeks prior randomization.
  • Subjects must have an ECOG performance status of 0 or 1 (See Appendix B).

  • Subjects must have adequate bone marrow, renal and hepatic function as defined by the following parameters obtained up to maximum 12 weeks prior to randomization:

    • Hematology:
    • WBC >= 3.0 x 109/L
    • Neutrophils > 1.5 x 109/L
    • Platelets > 100 x 109/L
    • Hemoglobin >= 9 g/dL or 5.6 mmol/L
    • Adequate Renal and Hepatic function:
    • Serum creatinine < 2.0 mg/dL or < 140 µmol/L
    • SGOT and SGPT < 2 times upper normal limit of laboratory normal (ULN)

Exclusion Criteria:

  • No mucosal melanoma nor ocular melanoma.
  • No evidence of nodal involvement confirmed by sentinel lymph node biopsy (SNB). Sentinel Node staging after the excision of the primary must be done between the date of final excision of the primary and the date of randomization.
  • No evidence of regional nor distant lymph node metastases nor satellites/in-transit metastases (even if they have been resected).
  • No evidence of distant metastasis on clinical examination, CT/MRI of full chest, abdomen and pelvis. Neck CT/MRI if head and neck primary.
  • No clinical evidence of brain metastasis.
  • No pregnant women
  • No breast feeding women
  • No patients with a medical condition requiring chronic systemic corticosteroids are not eligible.
  • No experimental therapy within 30 days prior to randomization in this study.
  • No prior chemotherapy, immunotherapy/vaccine, hormonal or radiation therapy for melanoma.
  • No prior treatment with interferon-alfa for any reason.
  • No history of prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
  • No severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) nor symptomatic ischemic heart disease.
  • No thyroid dysfunction not responsive to therapy.
  • No poorly controlled (HBA1C>8%) diabetes mellitus or uncontrolled diabetes mellitus, i.e. elevated fasting serum glucose should be < 110% ULN).
  • No active autoimmune disease.
  • No active and/or uncontrolled infection, including active hepatitis.
  • No history of seropositivity for HIV.
  • No history of neuropsychiatric disorder requiring hospitalization.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Observation
EXPERIMENTAL: PEG IFN alfa-2b
Biological: PEG IFN alfa-2b
3µg/kg weekly injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse-free survival (RFS)
Time Frame: 6.3 years from first patient in
6.3 years from first patient in

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of Adverse Events
Time Frame: 6.3 years from first patient in
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.
6.3 years from first patient in
Overall survival (OS)
Time Frame: 7.8 years from first patient in
7.8 years from first patient in
Distant metastases-free survival (DMFS)
Time Frame: 7.8 years from first patient in
7.8 years from first patient in
Quality of life
Time Frame: 6 years from from first patient in
6 years from from first patient in

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

Collaborators

NCIC Clinical Trials Group

Investigators

  • Study Chair: Alexander Eggermont, MD, PHD, INSTITUT GUSTAVE ROUSSY, Paris, France

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

October 1, 2012

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

December 29, 2011

First Posted (ESTIMATE)

January 2, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-18081
  • 2009-010273-20 (EUDRACT_NUMBER)

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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