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Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

Primary Purpose

Melanoma (Skin)

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GM2-KLH vaccine
QS21
adjuvant therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage II melanoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Perth Hospital
  • Hopital Universitaire Erasme
  • Cliniques Universitaires Saint-Luc
  • Universitair Ziekenhuis Antwerpen
  • Universitair Ziekenhuis Gent
  • Hopital de Jolimont
  • U.Z. Gasthuisberg
  • Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
  • Rigshospitalet - Copenhagen University Hospital
  • Herlev Hospital - University Hospital of Copenhagen
  • Odense University Hospital
  • North-Estonian Regional Hospital Surgical Oncology Centre
  • Tampere University Hospital
  • CHR de Besancon - Hopital Saint-Jacques
  • CHU Ambroise Pare
  • CHU de Caen
  • Centre Jean Perrin
  • Centre Hospitalier Regional et Universitaire de Lille
  • Hopital St. Eloi
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Hopital L'Archet - 2
  • Hopital Bichat - Claude Bernard
  • Hopital Saint-Louis
  • Centre Eugene Marquis
  • Centre Hospitalier Regional Metz Thionville
  • Centre Alexis Vautrin
  • Institut Gustave Roussy
  • Haematologisch-Onkologische Praxis Altona
  • Universitaets-Hautklinik Wuerzburg
  • Rambam Medical Center
  • Wolfson Medical Center
  • Centro di Riferimento Oncologico - Aviano
  • Ospendale S.M. Annunziata-A.S.DI Florence
  • Istituto Nazionale per la Ricerca sul Cancro
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • European Institute of Oncology
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Azienda Ospedaliera di Padova
  • Ospedale S. Camillo-Forlanini
  • Istituto Regina Elena
  • Universita Degli Studi di Turin
  • Leiden University Medical Center
  • Nijmegen Cancer Center at Radboud University Medical Center
  • Daniel Den Hoed Cancer Center at Erasmus Medical Center
  • Norwegian Radium Hospital
  • Great Poland Cancer Center
  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Instituto Portugues de Oncologia Centro do Porto, S. A.
  • Hospital Distrital De Santarem
  • Russian Academy of Medical Sciences Cancer Research Center
  • Institute of Oncology and Radiology of Serbia
  • Hospital Universitario 12 de Octubre
  • Hospital Clinico Universitario Lozano Blesa
  • Centre Hospitalier Universitaire Vaudois
  • Royal Sussex County Hospital
  • Bristol Haematology and Oncology Centre
  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  • Broomfield Hospital
  • Cheltenham General Hospital
  • Walsgrave Hospital
  • St. Luke's Cancer Centre at Royal Surrey County Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Saint Bartholomew's Hospital
  • Royal Free and University College Medical School
  • St. George's Hospital
  • Royal Marsden NHS Foundation Trust - London
  • Clatterbridge Centre for Oncology NHS Trust
  • James Cook University Hospital
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Nottingham City Hospital NHS Trust
  • Poole Hospital NHS Trust
  • Salisbury District Hospital
  • Cancer Research Centre at Weston Park Hospital
  • Southampton General Hospital
  • Southend NHS Trust Hospital
  • Ninewells Hospital and Medical School
  • Western General Hospital
  • Velindre Cancer Center at Velinde Hospital
  • Selly Oak Hospital at University Hospital NHS Trust

Outcomes

Primary Outcome Measures

Disease-free survival

Secondary Outcome Measures

Duration of survival
Toxicity as assessed by CTC v2

Full Information

First Posted
April 6, 2000
Last Updated
February 6, 2009
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00005052
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 Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage II melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
GM2-KLH vaccine
Intervention Type
Biological
Intervention Name(s)
QS21
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Disease-free survival
Secondary Outcome Measure Information:
Title
Duration of survival
Title
Toxicity as assessed by CTC v2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander M. M. Eggermont, MD, PhD
Organizational Affiliation
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Facility Information:
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Hopital de Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Aarhus University Hospital - Aarhus Sygehus - Norrebrogade
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Rigshospitalet - Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital - University Hospital of Copenhagen
City
Copenhagen
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
North-Estonian Regional Hospital Surgical Oncology Centre
City
Tallinn
ZIP/Postal Code
11619
Country
Estonia
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
CHR de Besancon - Hopital Saint-Jacques
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
F-92104
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Hospitalier Regional et Universitaire de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital St. Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital L'Archet - 2
City
Nice
ZIP/Postal Code
F-06202
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Hospitalier Regional Metz Thionville
City
Thionville
ZIP/Postal Code
57126
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Haematologisch-Onkologische Praxis Altona
City
Hamburg
ZIP/Postal Code
D-22765
Country
Germany
Facility Name
Universitaets-Hautklinik Wuerzburg
City
Wuerzburg
ZIP/Postal Code
D-97080
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospendale S.M. Annunziata-A.S.DI Florence
City
Firenze
ZIP/Postal Code
I-50011
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa (Genova)
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Milano (Milan)
ZIP/Postal Code
20133
Country
Italy
Facility Name
European Institute of Oncology
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale S. Camillo-Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Istituto Regina Elena
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Universita Degli Studi di Turin
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 CA
Country
Netherlands
Facility Name
Nijmegen Cancer Center at Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
Great Poland Cancer Center
City
Poznan
ZIP/Postal Code
61 866
Country
Poland
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Instituto Portugues de Oncologia Centro do Porto, S. A.
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Hospital Distrital De Santarem
City
Santarem
ZIP/Postal Code
2000
Country
Portugal
Facility Name
Russian Academy of Medical Sciences Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Institute of Oncology and Radiology of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Chelmsford, Essex
State/Province
England
ZIP/Postal Code
CM1 5ET
Country
United Kingdom
Facility Name
Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 5XX
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Free and University College Medical School
City
London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Poole Hospital NHS Trust
City
Poole Dorset
State/Province
England
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
State/Province
England
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Southend NHS Trust Hospital
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velinde Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF4 7XL
Country
United Kingdom
Facility Name
Selly Oak Hospital at University Hospital NHS Trust
City
Birmingham
ZIP/Postal Code
B29 6JD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
PubMed Identifier
21600759
Citation
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.
Results Reference
derived

Learn more about this trial

Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

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