Spots Global Cancer Trial Database for Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After Cystectomy
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Trial Identification
Brief Title: Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After Cystectomy
Official Title: A Randomized, Double Blind, Placebo Controlled Phase II Trial to Evaluate the Safety and Efficacy of recMAGE-A3 + AS15 ASCI in Patients With MAGE-A3 Positive Muscle Invasive Bladder Cancer After Cystectomy
Study ID: NCT01435356
Conditions
Study Description
Brief Summary: The purpose of this clinical trial was to demonstrate the benefit of the immunotherapeutic product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the bladder. A course of 13 injections was administered over 27 months.
Detailed Description: This study assessed an investigational treatment for patients with Muscle Invasive Bladder Cancer in whom the urinary bladder had been surgically removed. The investigational treatment aimed to increase the body's immune response to a specific antigen expressed by the cancer. The tumour tissue was first tested whether it expressed the MAGE-A3 antigen. The MAGNOLIA study was open to male and female patients with pathologically confirmed muscle invasive transitional cell carcinoma of the urinary bladder with expression of the antigen MAGE-A3 with or without limited lymph node involvement who had no evidence of disease after surgery confirmed with imaging procedures (scans CT/MRI).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Faculty teaching Hospital in Plzen, Plzen, , Czechia
Hospital Motol, Prague, , Czechia
Thomayerova nemocnice, Prague, , Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Usti nad Labem, , Czechia
Institut Bergonié, Bordeaux, , France
Hôpital Huriez, Lille, , France
Hôpital Edouard Herriot, Lyon, , France
Institut Curie, Paris, , France
Hôpital Rangueil, Toulouse, , France
Universitätsklinikum Aachen, Aachen, , Germany
Universitätsklinikum C.-G. Carus Dresden, Dresden, , Germany
Heinrich-Heine University, Düsseldorf, , Germany
Waldkrankenhaus St. Marien gGmbH, Erlangen, , Germany
Universitätsklinikum Giessen, Giessen, , Germany
Universitätsklinikum Jena, Jena, , Germany
Universitätsmedizin, Mannheim, , Germany
Universitätsklinikum Marburg, Marburg, , Germany
Klinikum rechts der Isar der TU München, München, , Germany
Universitätklinikum Rostock, Rostock, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universitaria Policlinico Consorziale di Bari, Bari, , Italy
Università Vita e Saluta, Milano, , Italy
Ospedaliera di Perugia, Perugia, , Italy
Universitaria Pisana, Pisa, , Italy
Università di Roma, La Sapienza, Rome, , Italy
NKI, Amsterdam, , Netherlands
St Antoniusziekenhuis, Nieuwegein, , Netherlands
RadboudUMC, Nijmegen, , Netherlands
Kliniczny Dzial Urologii Swietokrzyskiego Centrum Onkologii, Kielce, , Poland
Medical University of Warsaw, Warsaw, , Poland
Oddzial Urologii Miedzyleski Szpital Specjalistyczny w Warszawie, Warsaw, , Poland
Fundeni Clinical Institute, Bucharest, , Romania
Clinical County Emergency Hospital Craiova, Craiova, , Romania
Federal State Budget Institution "Scientific Research Institute of Urology" of the Ministry of Healthcare and Social Development of the Russian Federation, Moscow, , Russian Federation
Federal State Institution "Moscow Research Oncology Institute named after P.A. Gertsen" of the Ministry of Healthcare and Social Development of the Russian Federation, Moscow, , Russian Federation
Institution of the Russian Academy of Medical Science Russian Oncology Research Center named after N.N. Blokhin of RAMS, Moscow, , Russian Federation
Municipal Budget Institution of Health Care "Clinical Diagnostic Center "Zdorovie" of Rostov-on-Don city", Rostov-on-Don, , Russian Federation
Saint Petersburg State Institution of Health Care "City Multi-Field Hospital #2", St. Petersburg, , Russian Federation
Hospital Universitario A Coruña, A Coruña, , Spain
Hospital Universitario Principe de Asturias, Alcalá de Henares, , Spain
Hospital Universitario Fundación Alcorcón, Alcorcón, , Spain
Fundación Puigvert, Barcelona, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitario Puerta del Mar, Cádiz, , Spain
Hospital 12 de Octubre, Fundación de Investigación Biomédica, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Infanta Sofia, San Sebastián de los Reyes, , Spain
Kyiv City Clinical Oncology Hospital, Kiev, , Ukraine
Contact Details
Name: Peter FA Mulders, Prof,PhD,MD
Affiliation: EAU Research Foundation
Role: PRINCIPAL_INVESTIGATOR
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