Adjuvant PEG Intron in Ulcerated Melanoma

NCT ID: NCT01502696

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2019-04-30

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.

Conditions

Ulcerated Melanomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEG IFN alfa-2b

Group Type: EXPERIMENTAL

PEG IFN alfa-2b

Intervention Type: BIOLOGICAL

3µg/kg weekly injections

Observation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PEG IFN alfa-2b

3µg/kg weekly injections

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Eggermont, MD, PHD

Role: STUDY_CHAIR

Institut Gustave Roussy, Paris, France

Locations

Medical University of Graz

Graz, , Austria

Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

Brussels, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

U.Z. Leuven - Campus Gasthuisberg

Leuven, , Belgium

Aarhus University Hospital

Aarhus, , Denmark

Herlev Hospital - University Copenhagen

Herlev, , Denmark

Odense University Hospital

Odense, , Denmark

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

Salouël, , France

Universitaetsklinikum Koeln

Cologne, , Germany

Universitaetsklinikum

Essen, , Germany

Universitaetsklinikum Heidelberg - Hautklinik / Dermatologic Department

Heidelberg, , Germany

Universitaetsklinikum Heidelberg - Hautklinik

Heidelberg, , Germany

Universitaetsklinikum Schleswig-Holstein

Kiel, , Germany

Medizinische Universitaet Zu Luebeck

Lübeck, , Germany

Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

Mainz, , Germany

UniversitaetsMedizin Mannheim

Mannheim, , Germany

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

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

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

Amsterdam, , Netherlands

Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

Leiden University Medical Centre

Leiden, , Netherlands

Maria Sklodowska-Curie Memorial Cancer Centre

Warsaw, , Poland

I.P.O. Francisco Gentil - Centro De Lisboa

Lisbon, , Portugal

I.P.O. Francisco Gentil - Centro De Lisboa

Lisbon, , Portugal

Hospital Distrital De Santarem

Santarém, , Portugal

Hospital Clinic Universitari

Barcelona, , Spain

Hospital Universitario 12 De Octubre

Madrid, , Spain

UniversitaetsSpital Zurich

Zurich, , Switzerland

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

Countries

Austria; Belgium; Denmark; France; Germany; Italy; Netherlands; Poland; Portugal; Spain; Switzerland; United Kingdom

Other Identifiers

2009-010273-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EORTC-18081

Identifier Type: -

Identifier Source: org_study_id