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Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
This study is ongoing, but not recruiting participants.
First Received: April 6, 2000   Last Updated: February 6, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of survival [ Designated as safety issue: No ]
  • Toxicity as assessed by CTC v2 [ Designated as safety issue: Yes ]

Study Start Date: December 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005052

  Hide Study Locations
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
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Investigator: Alexander M. M. Eggermont, MD, PhD Daniel Den Hoed Cancer Center at Erasmus Medical Center
  More Information

Additional Information:
Publications:
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.

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

Keywords provided by National Cancer Institute (NCI):
stage II melanoma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 22, 2009