Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
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Trial Identification
Brief Title: Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
Official Title: 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
Study ID: NCT00005052
Conditions
Study Description
Brief Summary: 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.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Royal Perth Hospital, Perth, Western Australia, Australia
Hopital Universitaire Erasme, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent, Ghent, , Belgium
Hopital de Jolimont, Haine Saint Paul, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade, Aarhus, , Denmark
Rigshospitalet - Copenhagen University Hospital, Copenhagen, , Denmark
Herlev Hospital - University Hospital of Copenhagen, Copenhagen, , Denmark
Odense University Hospital, Odense, , Denmark
North-Estonian Regional Hospital Surgical Oncology Centre, Tallinn, , Estonia
Tampere University Hospital, Tampere, , Finland
CHR de Besancon - Hopital Saint-Jacques, Besancon, , France
CHU Ambroise Pare, Boulogne Billancourt, , France
CHU de Caen, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Hospitalier Regional et Universitaire de Lille, Lille, , France
Hopital St. Eloi, Montpellier, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, , France
Hopital L'Archet - 2, Nice, , France
Hopital Bichat - Claude Bernard, Paris, , France
Hopital Saint-Louis, Paris, , France
Centre Eugene Marquis, Rennes, , France
Centre Hospitalier Regional Metz Thionville, Thionville, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Haematologisch-Onkologische Praxis Altona, Hamburg, , Germany
Universitaets-Hautklinik Wuerzburg, Wuerzburg, , Germany
Rambam Medical Center, Haifa, , Israel
Wolfson Medical Center, Holon, , Israel
Centro di Riferimento Oncologico - Aviano, Aviano, , Italy
Ospendale S.M. Annunziata-A.S.DI Florence, Firenze, , Italy
Istituto Nazionale per la Ricerca sul Cancro, Genoa (Genova), , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano (Milan), , Italy
European Institute of Oncology, Milano, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples, , Italy
Azienda Ospedaliera di Padova, Padova, , Italy
Ospedale S. Camillo-Forlanini, Rome, , Italy
Istituto Regina Elena, Rome, , Italy
Universita Degli Studi di Turin, Torino, , Italy
Leiden University Medical Center, Leiden, , Netherlands
Nijmegen Cancer Center at Radboud University Medical Center, Nijmegen, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam, , Netherlands
Norwegian Radium Hospital, Oslo, , Norway
Great Poland Cancer Center, Poznan, , Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland
Instituto Portugues de Oncologia Centro do Porto, S. A., Porto, , Portugal
Hospital Distrital De Santarem, Santarem, , Portugal
Russian Academy of Medical Sciences Cancer Research Center, Moscow, , Russian Federation
Institute of Oncology and Radiology of Serbia, Belgrade, , Serbia
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, , Spain
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Royal Sussex County Hospital, Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, United Kingdom
Broomfield Hospital, Chelmsford, Essex, England, United Kingdom
Cheltenham General Hospital, Cheltenham, England, United Kingdom
Walsgrave Hospital, Coventry, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
Saint Bartholomew's Hospital, London, England, United Kingdom
Royal Free and University College Medical School, London, England, United Kingdom
St. George's Hospital, London, England, United Kingdom
Royal Marsden NHS Foundation Trust - London, London, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom
James Cook University Hospital, Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital, Newcastle-Upon-Tyne, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
Poole Hospital NHS Trust, Poole Dorset, England, United Kingdom
Salisbury District Hospital, Salisbury, England, United Kingdom
Cancer Research Centre at Weston Park Hospital, Sheffield, England, United Kingdom
Southampton General Hospital, Southampton, England, United Kingdom
Southend NHS Trust Hospital, Westcliff-On-Sea, England, United Kingdom
Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
Velindre Cancer Center at Velinde Hospital, Cardiff, Wales, United Kingdom
Selly Oak Hospital at University Hospital NHS Trust, Birmingham, , United Kingdom
Contact Details
Name: Alexander M. M. Eggermont, MD, PhD
Affiliation: Daniel Den Hoed Cancer Center at Erasmus Medical Center
Role:
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