Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
NCT ID: NCT00005052
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
INTERVENTIONAL
1999-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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GM2-KLH vaccine
QS21
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Principal Investigators
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Alexander M. M. Eggermont, MD, PhD
Role:
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Locations
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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
Besançon, , 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
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Haematologisch-Onkologische Praxis Altona
Hamburg, , Germany
Universitaets-Hautklinik Wuerzburg
Würzburg, , 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
Florence, , Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , Italy
European Institute of Oncology
Milan, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , Italy
Azienda Ospedaliera di Padova
Padua, , 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
Santarém, , Portugal
Russian Academy of Medical Sciences Cancer Research Center
Moscow, , Russia
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
Countries
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References
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Eggermont AM, Suciu S, Ruka W, et al.: EORTC 18961: Post-operative adjuvant ganglioside GM2-KLH21 vaccination treatment vs observation in stage II (T3-T4N0M0) melanoma: 2nd interim analysis led to an early disclosure of the results. [Abstract] J Clin Oncol 26 (Suppl 15): A-9004, 2008.
Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18.
Other Identifiers
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EORTC-18961
Identifier Type: -
Identifier Source: secondary_id
BMS-CA152-003
Identifier Type: -
Identifier Source: secondary_id
CDR0000067645
Identifier Type: -
Identifier Source: org_study_id
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