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Trial record 67 of 1273 for:    IFNA2

Adjuvant PEG Intron in Ulcerated 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: NCT01502696
Recruitment Status : Active, not recruiting
First Posted : January 2, 2012
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ulcerated Melanomas Biological: PEG IFN alfa-2b Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2012
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
Experimental: PEG IFN alfa-2b Biological: PEG IFN alfa-2b
3µg/kg weekly injections

No Intervention: Observation



Primary Outcome Measures :
  1. Relapse-free survival (RFS) [ Time Frame: 6.3 years from first patient in ]

Secondary Outcome Measures :
  1. 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.

  2. Overall survival (OS) [ Time Frame: 7.8 years from first patient in ]
  3. Distant metastases-free survival (DMFS) [ Time Frame: 7.8 years from first patient in ]
  4. Quality of life [ Time Frame: 6 years from from first patient in ]


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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

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.

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): NCT01502696


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

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01502696     History of Changes
Other Study ID Numbers: EORTC-18081
2009-010273-20 ( EudraCT Number )
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
ulcerated primary cutaneous melanoma
Stage II
PEG IFN alfa-2b
T(2-4)bN0M0

Additional relevant MeSH terms:
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Interferon-alpha
Interferon alpha-2
Melanoma
Ulcer
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pathologic Processes
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents