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Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Unknown status
CT.gov ID
NCT00005052
Collaborator
(none)
80
Locations

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: GM2-KLH vaccine
  • Biological: QS21
  • Procedure: adjuvant therapy
 Phase 3

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Dec 1, 1999

Outcome Measures

Primary Outcome Measures

  1. Disease-free survival []

Secondary Outcome Measures

  1. Duration of survival []

  2. Toxicity as assessed by CTC v2 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Royal Perth Hospital Perth Western Australia Australia 6000
2 Hopital Universitaire Erasme Brussels Belgium 1070
3 Cliniques Universitaires Saint-Luc Brussels Belgium 1200
4 Universitair Ziekenhuis Antwerpen Edegem Belgium B-2650
5 Universitair Ziekenhuis Gent Ghent Belgium B-9000
6 Hopital de Jolimont Haine Saint Paul Belgium 7100
7 U.Z. Gasthuisberg Leuven Belgium B-3000
8 Aarhus University Hospital - Aarhus Sygehus - Norrebrogade Aarhus Denmark DK-8000
9 Rigshospitalet - Copenhagen University Hospital Copenhagen Denmark 2100
10 Herlev Hospital - University Hospital of Copenhagen Copenhagen Denmark DK-2730
11 Odense University Hospital Odense Denmark DK-5000
12 North-Estonian Regional Hospital Surgical Oncology Centre Tallinn Estonia 11619
13 Tampere University Hospital Tampere Finland 33521
14 CHR de Besancon - Hopital Saint-Jacques Besancon France 25030
15 CHU Ambroise Pare Boulogne Billancourt France F-92104
16 CHU de Caen Caen France 14033
17 Centre Jean Perrin Clermont-Ferrand France 63011
18 Centre Hospitalier Regional et Universitaire de Lille Lille France 59037
19 Hopital St. Eloi Montpellier France 34295
20 Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Montpellier France 34298
21 Hopital L'Archet - 2 Nice France F-06202
22 Hopital Bichat - Claude Bernard Paris France 75018
23 Hopital Saint-Louis Paris France 75475
24 Centre Eugene Marquis Rennes France 35042
25 Centre Hospitalier Regional Metz Thionville Thionville France 57126
26 Centre Alexis Vautrin Vandoeuvre-les-Nancy France 54511
27 Institut Gustave Roussy Villejuif France F-94805
28 Haematologisch-Onkologische Praxis Altona Hamburg Germany D-22765
29 Universitaets-Hautklinik Wuerzburg Wuerzburg Germany D-97080
30 Rambam Medical Center Haifa Israel 31096
31 Wolfson Medical Center Holon Israel 58100
32 Centro di Riferimento Oncologico - Aviano Aviano Italy 33081
33 Ospendale S.M. Annunziata-A.S.DI Florence Firenze Italy I-50011
34 Istituto Nazionale per la Ricerca sul Cancro Genoa (Genova) Italy 16132
35 Istituto Nazionale per lo Studio e la Cura dei Tumori Milano (Milan) Italy 20133
36 European Institute of Oncology Milano Italy 20141
37 Istituto Nazionale per lo Studio e la Cura dei Tumori Naples Italy 80131
38 Azienda Ospedaliera di Padova Padova Italy 35128
39 Ospedale S. Camillo-Forlanini Rome Italy 00152
40 Istituto Regina Elena Rome Italy 00161
41 Universita Degli Studi di Turin Torino Italy 10126
42 Leiden University Medical Center Leiden Netherlands 2300 CA
43 Nijmegen Cancer Center at Radboud University Medical Center Nijmegen Netherlands NL-6500 HB
44 Daniel Den Hoed Cancer Center at Erasmus Medical Center Rotterdam Netherlands 3008 AE
45 Norwegian Radium Hospital Oslo Norway N-0310
46 Great Poland Cancer Center Poznan Poland 61 866
47 Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Warsaw Poland 02-781
48 Instituto Portugues de Oncologia Centro do Porto, S. A. Porto Portugal 4200
49 Hospital Distrital De Santarem Santarem Portugal 2000
50 Russian Academy of Medical Sciences Cancer Research Center Moscow Russian Federation 115478
51 Institute of Oncology and Radiology of Serbia Belgrade Serbia 11000
52 Hospital Universitario 12 de Octubre Madrid Spain 28041
53 Hospital Clinico Universitario Lozano Blesa Zaragoza Spain 50009
54 Centre Hospitalier Universitaire Vaudois Lausanne Switzerland CH-1011
55 Royal Sussex County Hospital Brighton England United Kingdom BN2 5BE
56 Bristol Haematology and Oncology Centre Bristol England United Kingdom BS2 8ED
57 Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust Cambridge England United Kingdom CB2 2QQ
58 Broomfield Hospital Chelmsford, Essex England United Kingdom CM1 5ET
59 Cheltenham General Hospital Cheltenham England United Kingdom GL53 7AN
60 Walsgrave Hospital Coventry England United Kingdom CV2 2DX
61 St. Luke's Cancer Centre at Royal Surrey County Hospital Guildford England United Kingdom GU2 5XX
62 Leeds Cancer Centre at St. James's University Hospital Leeds England United Kingdom LS9 7TF
63 Saint Bartholomew's Hospital London England United Kingdom EC1A 7BE
64 Royal Free and University College Medical School London England United Kingdom NW3 2QG
65 St. George's Hospital London England United Kingdom SW17 0QT
66 Royal Marsden NHS Foundation Trust - London London England United Kingdom SW3 6JJ
67 Clatterbridge Centre for Oncology NHS Trust Merseyside England United Kingdom CH63 4JY
68 James Cook University Hospital Middlesbrough England United Kingdom TS4 3BW
69 Northern Centre for Cancer Treatment at Newcastle General Hospital Newcastle-Upon-Tyne England United Kingdom NE4 6BE
70 Mount Vernon Cancer Centre at Mount Vernon Hospital Northwood England United Kingdom HA6 2RN
71 Nottingham City Hospital NHS Trust Nottingham England United Kingdom NG5 1PB
72 Poole Hospital NHS Trust Poole Dorset England United Kingdom BH15 2JB
73 Salisbury District Hospital Salisbury England United Kingdom SP2 8BJ
74 Cancer Research Centre at Weston Park Hospital Sheffield England United Kingdom S1O 2SJ
75 Southampton General Hospital Southampton England United Kingdom SO16 6YD
76 Southend NHS Trust Hospital Westcliff-On-Sea England United Kingdom SS0 0RY
77 Ninewells Hospital and Medical School Dundee Scotland United Kingdom DD1 9SY
78 Western General Hospital Edinburgh Scotland United Kingdom EH4 2XU
79 Velindre Cancer Center at Velinde Hospital Cardiff Wales United Kingdom CF4 7XL
80 Selly Oak Hospital at University Hospital NHS Trust Birmingham United Kingdom B29 6JD

Sponsors and Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • : Alexander M. M. Eggermont, MD, PhD, Daniel Den Hoed Cancer Center at Erasmus Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00005052
Other Study ID Numbers:
  • CDR0000067645
  • EORTC-18961
  • BMS-CA152-003
First Posted:
Jan 27, 2003
Last Update Posted:
Feb 9, 2009
Last Verified:
Jan 1, 2006
Keywords provided by , ,
stage II melanoma
Additional relevant MeSH terms:
Melanoma

Study Results

No Results Posted as of Feb 9, 2009