Melanoma (Skin)Phase 3NCT00005052
Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
A Phase 3 study testing GM2-KLH vaccine, QS21 and adjuvant therapy in people with Melanoma (Skin), run by European Organisation for Research and Treatment of Cancer - EORTC at 80 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- GM2-KLH vaccine, QS21 and adjuvant therapy
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- Not given
- Where
- 80 sitesin 18 countries
- Study dates
- Dec 1999to not given
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
80 sites in 18 countries.
80 sites in 18 countries
United Kingdom26 sites
Selly Oak Hospital at University Hospital NHS Trust
Birmingham, B29 6JD
Royal Sussex County Hospital
Brighton, England, BN2 5BE
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 2QQ
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, CF4 7XL
Broomfield Hospital
Chelmsford, Essex, England, CM1 5ET
Cheltenham General Hospital
Cheltenham, England, GL53 7AN
Walsgrave Hospital
Coventry, England, CV2 2DX
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
Western General Hospital
Edinburgh, Scotland, EH4 2XU
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 5XX
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Royal Free and University College Medical School
London, England, NW3 2QG
St. George's Hospital
London, England, SW17 0QT
Royal Marsden NHS Foundation Trust - London
London, England, SW3 6JJ
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, CH63 4JY
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Poole Hospital NHS Trust
Poole Dorset, England, BH15 2JB
Salisbury District Hospital
Salisbury, England, SP2 8BJ
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Southampton General Hospital
Southampton, England, SO16 6YD
Southend NHS Trust Hospital
Westcliff-on-Sea, England, SS0 0RY
France14 sites
CHR de Besancon - Hopital Saint-Jacques
Besançon, 25030
CHU Ambroise Pare
Boulogne-Billancourt, F-92104
CHU de Caen
Caen, 14033
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Hospitalier Regional et Universitaire de Lille
Lille, 59037
Hopital St. Eloi
Montpellier, 34295
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Hopital L'Archet - 2
Nice, F-06202
Hopital Bichat - Claude Bernard
Paris, 75018
Hopital Saint-Louis
Paris, 75475
Centre Eugene Marquis
Rennes, 35042
Centre Hospitalier Regional Metz Thionville
Thionville, 57126
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, F-94805
Italy10 sites
Centro di Riferimento Oncologico - Aviano
Aviano, 33081
Ospendale S.M. Annunziata-A.S.DI Florence
Florence, I-50011
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), 16132
European Institute of Oncology
Milan, 20141
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), 20133
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, 80131
Azienda Ospedaliera di Padova
Padova, 35128
Ospedale S. Camillo-Forlanini
Rome, 00152
Istituto Regina Elena
Rome, 00161
Universita Degli Studi di Turin
Torino, 10126
Belgium6 sites
Hopital Universitaire Erasme
Brussels, 1070
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
Universitair Ziekenhuis Gent
Ghent, B-9000
Hopital de Jolimont
Haine-Saint-Paul, 7100
U.Z. Gasthuisberg
Leuven, B-3000
Denmark4 sites
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
Aarhus, DK-8000
Rigshospitalet - Copenhagen University Hospital
Copenhagen, 2100
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, DK-2730
Odense University Hospital
Odense, DK-5000
Netherlands3 sites
Leiden University Medical Center
Leiden, 2300 CA
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, NL-6500 HB
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, 3008 AE
Germany2 sites
Haematologisch-Onkologische Praxis Altona
Hamburg, D-22765
Universitaets-Hautklinik Wuerzburg
Würzburg, D-97080
Israel2 sites
Rambam Medical Center
Haifa, 31096
Wolfson Medical Center
Holon, 58100
Poland2 sites
Great Poland Cancer Center
Poznan, 61 866
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781
Portugal2 sites
Instituto Portugues de Oncologia Centro do Porto, S. A.
Porto, 4200
Hospital Distrital De Santarem
Santarém, 2000
Spain2 sites
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Estonia1 site
North-Estonian Regional Hospital Surgical Oncology Centre
Tallinn, 11619
Russia1 site
Russian Academy of Medical Sciences Cancer Research Center
Moscow, 115478
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
About this study
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
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.
Read the 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.
- Conditions
- Melanoma (Skin)
- Being tested
- GM2-KLH vaccine, QS21, adjuvant therapy
- Keywords
- stage II melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM2-KLH vaccineBiological
QS21Biological
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Secondary outcomes (2)
Duration of survival
Toxicity as assessed by CTC v2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Sponsor and investigators
- Sponsor type
- Research network
- Investigators
- Alexander M. M. Eggermont, MD, PhD, Daniel Den Hoed Cancer Center at Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005052
- Sponsor's protocol ID
- CDR0000067645
- Other IDs
- EORTC-18961, BMS-CA152-003
- Status last verified
- Jan 2006
- First submitted
- 6 Apr 2000
- Last updated
- 9 Feb 2009
- Results posted
- No
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.
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.
PubMed 21600759