Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

February 6, 2009 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination: Post-Operative Adjuvant Ganglioside GM2-KLH/QS-21 (BMS-248479) Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 1.5mm (AJCC/UICC Stage II, T3-T4N0M0), a 2-Arm Multicenter Randomized Phase III Trial vs. Observation

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma.

PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the effect of immunization with GM2-KLH and QS21 to observation on the disease-free survival of patients with primary cutaneous stage II melanoma after adequate surgery.
  • Determine overall survival and toxicity in the two treatment arms.

OUTLINE: This is a randomized, open-label, parallel, multicenter study. Patients are stratified according to participating center, tumor thickness (greater than 1.5 to 3.0 mm vs greater than 3.0 to 4.0 mm vs greater than 4.0 mm), gender, ulceration (yes vs no), and presence of additional staging procedures of regional lymph nodes (yes vs no). Patients are randomized to one of two arms.

  • Arm I: Patients are vaccinated with GM2-KLH and QS21 subcutaneously on day 1 of weeks 1-4, 12, 24, 36, 48, 60, 72, 84, 96, 120, and 144 for a total of 14 vaccinations.
  • Arm II: Patients undergo observation. Patients are followed every 6 months for 7 years.

PROJECTED ACCRUAL: A total of 1300 patients (650 per arm) will be accrued for this study within 36 months.

Study Type

Interventional

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
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc
      • Brussels, Belgium, 1070
        • Hopital Universitaire Erasme
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Ghent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Haine Saint Paul, Belgium, 7100
        • Hôpital de Jolimont
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Denmark
      • Aarhus, Denmark, DK-8000
        • Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
      • Copenhagen, Denmark, 2100
        • Rigshospitalet - Copenhagen University Hospital
      • Copenhagen, Denmark, DK-2730
        • Herlev Hospital - University Hospital of Copenhagen
      • Odense, Denmark, DK-5000
        • Odense University Hospital
  • Estonia
      • Tallinn, Estonia, 11619
        • North-Estonian Regional Hospital Surgical Oncology Centre
  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital
  • France
      • Besancon, France, 25030
        • CHR de Besancon - Hopital Saint-Jacques
      • Boulogne Billancourt, France, F-92104
        • CHU Ambroise Pare
      • Caen, France, 14033
        • CHU de Caen
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Lille, France, 59037
        • Centre Hospitalier Regional et Universitaire de Lille
      • 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
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Thionville, France, 57126
        • Centre Hospitalier Regional Metz Thionville
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Hamburg, Germany, D-22765
        • Haematologisch-Onkologische Praxis Altona
      • Wuerzburg, Germany, D-97080
        • Universitaets-Hautklinik Wuerzburg
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Holon, Israel, 58100
        • Wolfson Medical Center
  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico - Aviano
      • Firenze, Italy, I-50011
        • Ospendale S.M. Annunziata-A.S.DI Florence
      • Genoa (Genova), Italy, 16132
        • Istituto nazionale Per la Ricerca sul Cancro
      • Milano, Italy, 20141
        • European Institute of Oncology
      • 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
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova
      • Rome, Italy, 00152
        • Ospedale S. Camillo-Forlanini
      • Rome, Italy, 00161
        • Istituto Regina Elena
      • Torino, Italy, 10126
        • Universita Degli Studi di Turin
  • Netherlands
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Nijmegen, Netherlands, NL-6500 HB
        • Nijmegen Cancer Center at Radboud University Medical Center
      • Rotterdam, Netherlands, 3008 AE
        • Daniel Den Hoed Cancer Center at Erasmus Medical Center
  • Norway
      • Oslo, Norway, N-0310
        • Norwegian Radium Hospital
  • Poland
      • Poznan, Poland, 61 866
        • Great Poland Cancer Center
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Portugal
      • Porto, Portugal, 4200
        • Instituto Portugues de Oncologia Centro do Porto, S. A.
      • Santarem, Portugal, 2000
        • Hospital Distrital de Santarém
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Russian Academy of Medical Sciences Cancer Research Center
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Oncology and Radiology of Serbia
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
  • United Kingdom
      • Birmingham, United Kingdom, B29 6JD
        • Selly Oak Hospital at University Hospital NHS Trust
    • England
      • Brighton, England, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
      • Chelmsford, Essex, England, United Kingdom, CM1 5ET
        • Broomfield Hospital
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Guildford, England, United Kingdom, GU2 5XX
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University 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, SW3 6JJ
        • Royal Marsden NHS Foundation Trust - London
      • London, England, United Kingdom, NW3 2QG
        • Royal Free and University College Medical School
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Poole Dorset, England, United Kingdom, BH15 2JB
        • Poole Hospital NHS Trust
      • Salisbury, England, United Kingdom, SP2 8BJ
        • Salisbury District Hospital
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Southend NHS Trust Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Western General Hospital
    • 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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary stage II melanoma greater than 1.5 mm without evidence of lymph node metastases

    • T3 or T4, N0, M0
    • Must originate in the skin

  • Wide excision with a minimum of 1-2 cm margin surrounding primary lesion or biopsy scar

    • No more than 56 days since definitive surgical treatment (wide excision)
    • No more than 12 weeks since primary surgery
  • No clinical, radiological, or pathological evidence of incompletely resected disease, lymph node metastases, in-transit metastasis, or any distant metastatic disease

PATIENT CHARACTERISTICS:

Age:

  • 18 to 80

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.8 g/dL

Hepatic:

  • SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN
  • LDH no greater than 2 times ULN
  • Bilirubin no greater than 2 times ULN
  • Hepatitis B and C negative

Renal:

  • Creatinine normal

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • No prior or other concurrent cancer except carcinoma in situ of the cervix or basal or squamous cell skin cancer
  • No autoimmune disorders
  • No conditions requiring systemic treatment with immunosuppressive drugs including treatment with systemic corticosteroids
  • No history of CNS demyelinating or inflammatory disease
  • No hereditary or acquired peripheral neuropathy
  • No other significant medical or surgical condition or psychiatric disorders requiring medication that would preclude study
  • No history of severe allergic reaction to shellfish
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy
  • No other concurrent biologic therapy

Chemotherapy:

  • No prior systemic chemotherapy
  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except replacement therapy
  • No concurrent corticosteroids
  • No concurrent chronic systemic steroids

Radiotherapy:

  • No prior adjuvant radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No prior preoperative infusion or perfusion therapy
  • No concurrent immunosuppressive medications
  • No other concurrent anticancer therapy

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
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease-free survival

Secondary Outcome Measures

Outcome Measure
Duration of survival
Toxicity as assessed by CTC v2

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

  • 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

December 1, 1999

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067645
  • EORTC-18961
  • BMS-CA152-003

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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