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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005052 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: GM2-KLH vaccine Biological: QS21 Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| 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 Start Date: | December 1999 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 1300 patients (650 per arm) will be accrued for this study within 36 months.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary stage II melanoma greater than 1.5 mm without evidence of lymph node metastases
Wide excision with a minimum of 1-2 cm margin surrounding primary lesion or biopsy scar
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| Australia, Western Australia | |
| Royal Perth Hospital | |
| Perth, Western Australia, Australia, 6000 | |
| Belgium | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, 1200 | |
| Hopital de Jolimont | |
| Haine Saint Paul, Belgium, 7100 | |
| Hopital Universitaire Erasme | |
| Brussels, Belgium, 1070 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Universitair Ziekenhuis Gent | |
| Ghent, Belgium, B-9000 | |
| Denmark | |
| Aarhus University Hospital - Aarhus Sygehus - Norrebrogade | |
| Aarhus, Denmark, DK-8000 | |
| Herlev Hospital - University Hospital of Copenhagen | |
| Copenhagen, Denmark, DK-2730 | |
| Odense University Hospital | |
| Odense, Denmark, DK-5000 | |
| Rigshospitalet - Copenhagen University Hospital | |
| Copenhagen, Denmark, 2100 | |
| Estonia | |
| North-Estonian Regional Hospital Surgical Oncology Centre | |
| Tallinn, Estonia, 11619 | |
| Finland | |
| Tampere University Hospital | |
| Tampere, Finland, 33521 | |
| France | |
| Centre Alexis Vautrin | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Centre Eugene Marquis | |
| Rennes, France, 35042 | |
| CHR de Besancon - Hopital Saint-Jacques | |
| Besancon, France, 25030 | |
| Centre Hospitalier Regional Metz Thionville | |
| Thionville, France, 57126 | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
| Montpellier, France, 34298 | |
| Centre Hospitalier Regional et Universitaire de Lille | |
| Lille, France, 59037 | |
| CHU Ambroise Pare | |
| Boulogne Billancourt, France, F-92104 | |
| CHU de Caen | |
| Caen, France, 14033 | |
| Hopital Bichat - Claude Bernard | |
| Paris, France, 75018 | |
| Hopital L'Archet - 2 | |
| Nice, France, F-06202 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Hopital St. Eloi | |
| Montpellier, France, 34295 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Germany | |
| Haematologisch-Onkologische Praxis Altona | |
| Hamburg, Germany, D-22765 | |
| Universitaets-Hautklinik Wuerzburg | |
| Wuerzburg, Germany, D-97080 | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Wolfson Medical Center | |
| Holon, Israel, 58100 | |
| Italy | |
| Azienda Ospedaliera di Padova | |
| Padova, Italy, 35128 | |
| Centro di Riferimento Oncologico - Aviano | |
| Aviano, Italy, 33081 | |
| European Institute of Oncology | |
| Milano, Italy, 20141 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa (Genova), Italy, 16132 | |
| Ospendale S.M. Annunziata-A.S.DI Florence | |
| Firenze, Italy, I-50011 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Milano (Milan), Italy, 20133 | |
| Istituto Regina Elena | |
| Rome, Italy, 00161 | |
| Ospedale S. Camillo-Forlanini | |
| Rome, Italy, 00152 | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Naples, Italy, 80131 | |
| Universita Degli Studi di Turin | |
| Torino, Italy, 10126 | |
| Netherlands | |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Nijmegen Cancer Center at Radboud University Medical Center | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Norway | |
| Norwegian Radium Hospital | |
| Oslo, Norway, N-0310 | |
| Poland | |
| Great Poland Cancer Center | |
| Poznan, Poland, 61 866 | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
| Warsaw, Poland, 02-781 | |
| Portugal | |
| Hospital Distrital De Santarem | |
| Santarem, Portugal, 2000 | |
| Instituto Portugues de Oncologia Centro do Porto, S. A. | |
| Porto, Portugal, 4200 | |
| Russian Federation | |
| Russian Academy of Medical Sciences Cancer Research Center | |
| Moscow, Russian Federation, 115478 | |
| Serbia | |
| Institute of Oncology and Radiology of Serbia | |
| Belgrade, Serbia, 11000 | |
| Spain | |
| Hospital Clinico Universitario Lozano Blesa | |
| Zaragoza, Spain, 50009 | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| United Kingdom | |
| Selly Oak Hospital at University Hospital NHS Trust | |
| Birmingham, United Kingdom, B29 6JD | |
| United Kingdom, England | |
| Cheltenham General Hospital | |
| Cheltenham, England, United Kingdom, GL53 7AN | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Broomfield Hospital | |
| Chelmsford, Essex, England, United Kingdom, CM1 5ET | |
| Cancer Research Centre at Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, CH63 4JY | |
| James Cook University Hospital | |
| Middlesbrough, England, United Kingdom, TS4 3BW | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | |
| Northwood, England, United Kingdom, HA6 2RN | |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
| Royal Sussex County Hospital | |
| Brighton, England, United Kingdom, BN2 5BE | |
| Poole Hospital NHS Trust | |
| Poole Dorset, England, United Kingdom, BH15 2JB | |
| Royal Free and University College Medical School | |
| London, England, United Kingdom, NW3 2QG | |
| Royal Marsden NHS Foundation Trust - London | |
| London, England, United Kingdom, SW3 6JJ | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| Salisbury District Hospital | |
| Salisbury, England, United Kingdom, SP2 8BJ | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Southend NHS Trust Hospital | |
| Westcliff-On-Sea, England, United Kingdom, SS0 0RY | |
| St. George's Hospital | |
| London, England, United Kingdom, SW17 0QT | |
| St. Luke's Cancer Centre at Royal Surrey County Hospital | |
| Guildford, England, United Kingdom, GU2 5XX | |
| Walsgrave Hospital | |
| Coventry, England, United Kingdom, CV2 2DX | |
| United Kingdom, Scotland | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| United Kingdom, Wales | |
| Velindre Cancer Center at Velinde Hospital | |
| Cardiff, Wales, United Kingdom, CF4 7XL | |
| Investigator: | Alexander M. M. Eggermont, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
More Information
| Study ID Numbers: | CDR0000067645, EORTC-18961, BMS-CA152-003 |
| Study First Received: | April 6, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005052 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II melanoma |
|
Neoplasms by Histologic Type Immunologic Factors Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Neoplasms, Germ Cell and Embryonal Nevi and Melanomas QS 21 |