Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

NCT00005052 | Unknown Phase 3

• 3 other identifiers: CDR0000067645EORTC-18961BMS-CA152-003
• Study Type: interventional
• Target: N/A
• Locations: 17 countries
• Sites: 79

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.

Conditions

Melanoma (Skin)

Keywords

stage II melanoma

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

Secondary Outcomes (2)

• Duration of survival

• Toxicity as assessed by CTC v2

Interventions

GM2-KLH vaccine BIOLOGICAL

QS21 BIOLOGICAL

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (80)

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

Aarhus, DK-8000, Denmark

Location

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Herlev Hospital - University Hospital of Copenhagen

Copenhagen, DK-2730, Denmark

Location

Odense University Hospital

Odense, DK-5000, Denmark

Location

North-Estonian Regional Hospital Surgical Oncology Centre

Tallinn, 11619, Estonia

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

CHR de Besancon - Hopital Saint-Jacques

Besançon, 25030, France

Location

CHU Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Hospitalier Regional et Universitaire de Lille

Lille, 59037, France

Location

Hopital St. Eloi

Montpellier, 34295, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Hopital L'Archet - 2

Nice, F-06202, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Hospitalier Regional Metz Thionville

Thionville, 57126, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Haematologisch-Onkologische Praxis Altona

Hamburg, D-22765, Germany

Location

Universitaets-Hautklinik Wuerzburg

Würzburg, D-97080, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Wolfson Medical Center

Holon, 58100, Israel

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Ospendale S.M. Annunziata-A.S.DI Florence

Florence, I-50011, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa (Genova), 16132, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milano (Milan), 20133, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Ospedale S. Camillo-Forlanini

Rome, 00152, Italy

Location

Istituto Regina Elena

Rome, 00161, Italy

Location

Universita Degli Studi di Turin

Torino, 10126, Italy

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Nijmegen Cancer Center at Radboud University Medical Center

Nijmegen, NL-6500 HB, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Great Poland Cancer Center

Poznan, 61 866, Poland

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Instituto Portugues de Oncologia Centro do Porto, S. A.

Porto, 4200, Portugal

Location

Hospital Distrital De Santarem

Santarém, 2000, Portugal

Location

Russian Academy of Medical Sciences Cancer Research Center

Moscow, 115478, Russia

Location

Institute of Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Broomfield Hospital

Chelmsford, Essex, England, CM1 5ET, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 5XX, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Royal Free and University College Medical School

London, England, NW3 2QG, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Royal Marsden NHS Foundation Trust - London

London, England, SW3 6JJ, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Poole Hospital NHS Trust

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Salisbury District Hospital

Salisbury, England, SP2 8BJ, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Southend NHS Trust Hospital

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Velindre Cancer Center at Velinde Hospital

Cardiff, Wales, CF4 7XL, United Kingdom

Location

Selly Oak Hospital at University Hospital NHS Trust

Birmingham, B29 6JD, United Kingdom

Location

Related Publications (2)

• 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.

  RESULT

• 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.

  PMID: 21600759 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

saponin QA-21V1; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Alexander M. M. Eggermont, MD, PhD

  Daniel Den Hoed Cancer Center at Erasmus Medical Center

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: January 27, 2003
• Study Start: December 1, 1999
• Last Updated: February 9, 2009

Record last verified: 2006-01

Locations

CH (1); ES (2); DE (2); SE (1); NL (3); IL (2); IT (10); DK (4); NO (1); RU (1); FI (1); AU (1); GB (26); PT (2); PL (2); BE (6); FR (14)