Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

Melanoma (Skin) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00005052
• Other study ID #: CDR0000067645
• Secondary ID: EORTC-18961BMS-C
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 6, 2000
• Last updated: February 6, 2009
• Start date: December 1999

Study information

• Verified date: January 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• GM2-KLH vaccine

• QS21

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
Australia	Royal Perth Hospital	Perth	Western Australia
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hopital Universitaire Erasme	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Gent	Ghent
Belgium	Hopital de Jolimont	Haine Saint Paul
Belgium	U.Z. Gasthuisberg	Leuven
Denmark	Aarhus University Hospital - Aarhus Sygehus - Norrebrogade	Aarhus
Denmark	Herlev Hospital - University Hospital of Copenhagen	Copenhagen
Denmark	Rigshospitalet - Copenhagen University Hospital	Copenhagen
Denmark	Odense University Hospital	Odense
Estonia	North-Estonian Regional Hospital Surgical Oncology Centre	Tallinn
Finland	Tampere University Hospital	Tampere
France	CHR de Besancon - Hopital Saint-Jacques	Besancon
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	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Hopital St. Eloi	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	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif
Germany	Haematologisch-Onkologische Praxis Altona	Hamburg
Germany	Universitaets-Hautklinik Wuerzburg	Wuerzburg
Israel	Rambam Medical Center	Haifa
Israel	Wolfson Medical Center	Holon
Italy	Centro di Riferimento Oncologico - Aviano	Aviano
Italy	Ospendale S.M. Annunziata-A.S.DI Florence	Firenze
Italy	Istituto Nazionale per la Ricerca sul Cancro	Genoa (Genova)
Italy	European Institute of Oncology	Milano
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	Padova
Italy	Istituto Regina Elena	Rome
Italy	Ospedale S. Camillo-Forlanini	Rome
Italy	Universita Degli Studi di Turin	Torino
Netherlands	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
Norway	Norwegian Radium Hospital	Oslo
Poland	Great Poland Cancer Center	Poznan
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Warsaw
Portugal	Instituto Portugues de Oncologia Centro do Porto, S. A.	Porto
Portugal	Hospital Distrital De Santarem	Santarem
Russian Federation	Russian Academy of Medical Sciences Cancer Research Center	Moscow
Serbia	Institute of Oncology and Radiology of Serbia	Belgrade
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Selly Oak Hospital at University Hospital NHS Trust	Birmingham
United Kingdom	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	Velindre Cancer Center at Velinde Hospital	Cardiff	Wales
United Kingdom	Broomfield Hospital	Chelmsford, Essex	England
United Kingdom	Cheltenham General Hospital	Cheltenham	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Western General Hospital	Edinburgh	Scotland
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	Royal Free and University College Medical School	London	England
United Kingdom	Royal Marsden NHS Foundation Trust - London	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. George's Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Australia,  Belgium,  Denmark,  Estonia,  Finland,  France,  Germany,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Portugal,  Russian Federation,  Serbia,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

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 Onco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival			No
Secondary	Duration of survival			No
Secondary	Toxicity as assessed by CTC v2			Yes