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Brief Title: Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients
Official Title: A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy
Study ID: NCT00418574
Brief Summary: The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.
Detailed Description: Standard initial treatment of ovarian cancer patients includes both surgery and chemotherapy which in the vast majority of cases achieves the disappearance of ovarian cancer lesions. This status, called "clinical remission" which means having no evidence of cancer on CT scan or physical examination needs to be carefully follow up in order to confirm the maintenance of the remission status or to early detect if the cancer grows again and then start a new chemotherapy. At present, no approved therapies exist for the maintenance treatment of patients who achieved the clinical remission. This trial aims to evaluate if the repeated vaccination with Abagovomab creates an immunoresponse which is able to fight the cancer cells thus keeping the remission status as long as possible and help patients live disease-free and longer. Patients who achieve the remission status after chemotherapy will be screened for study participation and if they meet the criteria for inclusion they will start to receive a single subcutaneous injection every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase). The duration of treatment is up to approximately 4 years or it will be stopped in case relapse occurs. In order to evaluate the real benefit of vaccination, the experimental treatment includes Abagovomab (the active drug) or placebo (the vehicle only, without drug), with a double chance to receive Abagovomab. Assignment of Abagovomab or placebo will be done by a computerised system and nobody in the study will know which treatment has been allocated until study end. Patients will be visited every 4 weeks and will undergo CT scan of pelvis and abdomen every 12 weeks in order to confirm the remission status or to early detect if relapse eventually occurs. This will be done in blind condition (i.e. without being aware which treatment the patient is going to receive) for the first part of the study which is expected to last four years. After then the overall status of patient will continue to be monitored by phone contact for additional five years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Cedars-Sinai Medical Center, Los Angeles, California, United States
University of California, Los Angeles (UCLA), Los Angeles, California, United States
Stanford University, Stanford, California, United States
University of Colorado, Denver, Colorado, United States
University of Connecticut Health Center, Farmington, Connecticut, United States
University of Miami, Miami, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Curtis and Elizabeth Anderson Cancer Institute, Savannah, Georgia, United States
Indiana University Cancer Pavilion, Indianapolis, Indiana, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Wayne State University, Detroit, Michigan, United States
Washington University, Saint Louis, Missouri, United States
The Cancer Care Center, Saint Louis, Missouri, United States
Women's Cancer Center, Las Vegas, Nevada, United States
Hackensack University Medical Center, Obstetrics and Gynecology Oncology, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Centre, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Women and Infants Hospital of Rhode Island, Providence, Rhode Island, United States
The West Clinic, Memphis, Tennessee, United States
Algemeen Stedelijk Ziekenhuis Aalst, Aalst, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
Universitair Ziekenhuis Gent Medische Oncologie 4B-Z, Gent, , Belgium
CHU de Liége (Sart Tilman), Liège, , Belgium
Clinique Sainte Elizabeth, Namur, , Belgium
AZ Sint Augustinus, Oncologisch Centrum GVA, Wilrijk, , Belgium
Fakultni nemocnice Brno, Brno, , Czech Republic
MOU Zluty Kopec, Brno, , Czech Republic
Nemocnice Ceske Budejovice, a.s., Ceske Budejovice, , Czech Republic
Fakultni nemocnice Hradec Kralove, Hradec Králové, , Czech Republic
Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke, Liberec, , Czech Republic
Fakultni nemocnice Olomouc, Olomouc, , Czech Republic
Fakultni Nemocnice Ostrava, Ostrava, , Czech Republic
Krajska nemocnice, Pardubice, , Czech Republic
Gynekologicko-porodnicka klinika FN Plzen, Plzen, , Czech Republic
Vseobecna Fakultni Nemocnice, Praha 2, , Czech Republic
Fakultni nemocnice Bulovka, Praha 8, , Czech Republic
Fakultni nemocnice Královské Vinohrady, Praha, , Czech Republic
Krajska nemocnice T. Bati, Zlin, , Czech Republic
Institut Bergonié, Bordeaux Cedex, , France
Centre Jean Bernard, Le Mans Cedex, , France
Centre Catherine de Sienne, Nantes Cedex, , France
Hôpital Hotel Dieu, Paris, , France
Helios Kliniken GmbH, Klinikum Buch, Berlin, , Germany
Charité - Campus Virchow Klinikum, Berlin, , Germany
Universitätsklinikum Bonn, Bonn, , Germany
Klinikum Bremen-Mitte gGmbH, Bremen, , Germany
Klinikum Chemnitz GmbH, Chemnitz, , Germany
St.-Josefs-Hospital Cloppenburg, Cloppenburg, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Evangelisches Krankenhaus, Düsseldorf, , Germany
Kreisklinik Ebersberg gGmbH, Ebersberg, , Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
Universitätsklinikum, Essen, , Germany
Klinikum der JWG Universität Frankfurt, Frankfurt, , Germany
Universitätsklinikum, Freiburg, , Germany
Klinikum der Ernst-Moritz-Universität, Greifswald, , Germany
Universitätsklinikum, Göttingen, , Germany
Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät, Halle/Saale, , Germany
Universitätskrankenhaus Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Jena, Jena, , Germany
St. Vincentius Kliniken AG, Karlsruhe, , Germany
Klinikum Kassel, Kassel, , Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, , Germany
Klinikum der Universität zu Köln, Köln, , Germany
Kreiskrankenhaus Leonberg, Leonberg, , Germany
Asklepios Klinik Lich, Lich, , Germany
Vincenz-Krankenhaus, Limburg, , Germany
Klinik St. Marienstift, Magdeburg, , Germany
Städtisches Klinikum Magdeburg, Magdeburg, , Germany
Otto-von-Guericke-Universität, Magdeburg, , Germany
Johannes-Gutenberg-Universität, Mainz, , Germany
Universitätsklinikum Gießen u. Marburg, Marburg, , Germany
Klinikum der Universität München-Innenstadt, München, , Germany
Klinikum Großhadern, München, , Germany
Klinikum rechts der Isar, München, , Germany
Klinikum Offenbach GmbH, Offenbach, , Germany
St. Vincenz-Krankenhaus Paderborn, Paderborn, , Germany
Elblandkliniken Meißen-Radebeul GmbH, Radebeul, , Germany
Krankenhaus St. Josef, Regensburg, , Germany
Klinikum Südstadt der Hansestadt Rostock, Rostock, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universitätsklinikum, Ulm, , Germany
Klinikum der Stadt Villingen-Schwenningen GmbH, Villingen-Schwenningen, , Germany
St. Josefs-Hospital, Wiesbaden, , Germany
r. Horst Schmidt Kliniken GmbH, Wiesbaden, , Germany
Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg, Wolfsburg, , Germany
Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia, Budapest, , Hungary
Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika, Budapest, , Hungary
Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika, Budapest, , Hungary
Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészetl es Nőgyógyászatl Klinika, Debrecen, , Hungary
Petz Aladar Megyei Oktató Kórház, Onkoradiológia, Győr, , Hungary
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Kórháza, Szülészet-Nőgyógyászati Osztály, Nyíregyháza, , Hungary
Pécsi Tudományegyetem, ÁOK Szülészeti és Nőgyógyászati Klinika, Pécs, , Hungary
Komárom-Esztergom Megyei Onkormanyzat Szent Borbála Kórház, Szülészet-Nőgyógyászati Osztály, Tatabanya, , Hungary
Unità Operativa Ginecologia e Ostetricia 2^, Università degli studi di Bari, Policlinico, Bari, , Italy
Ospedale S. Orsola Malpighi, Oncologia Medica, Bologna, , Italy
Universtita' Cattolica del Sacro Cuore Dipartimento di Oncologia, Campobasso, , Italy
DH Oncologico U.O. Medicina Oncologica Ospedale Ramazzini, Carpi (MO), , Italy
Oncologia Medica Ospedale di Faenza - AUSL di Ravenna, Faenza, , Italy
Azienda Ospedaliera - Universitaria Careggi, Firenze, , Italy
Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica, Genova, , Italy
Istituto Nazionale dei Tumori di Milano, Milano, , Italy
Istituto Europeo di Oncologia - Divisione di Ginecologia, Milano, , Italy
Policlinico di Modena, Dipartimento di Oncologia ed Ematologia, Modena, , Italy
Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica, Napoli, , Italy
Azienda Ospedaliera San Carlo - Oncologia Medica, Potenza, , Italy
Ospedali Riuniti Bianchi-Melacrino-Morelli - Oncologia Medica, Reggio di Calabria, , Italy
Arcispedale Santa Maria Nuova, Oncologia Medica, Reggio Emilia, , Italy
Policlinico Umberto I D.H. Oncologico Oncologia Medica, Roma, , Italy
Dipartimento di Ginecologia ed Ostetricia Policlinico Universitario Gemelli, Roma, , Italy
Ospedale Casa Sollievo della Sofferenza - Unita' Operativa di Ostetricia e Ginecologia, San Giovanni Rotondo (FG), , Italy
Dipartimento di Discipline Ginecologiche e Ostetriche - Universita degli Studi di Torino - Azienda ospedaliera O.I.R.M.-S'Anna, Torino, , Italy
Wojewódzki Szpital Specjalistyczny Nr 4, Bytom, , Poland
Oddzial Onkologii Wojewódzki Szpital Specjalistyczny, Czestochowa, , Poland
Wojewodzkie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Gdansk, , Poland
Vesalius Kraków, Krakow, , Poland
"Centrum Onkologii, Instytut im. M. Skłodowskiej-Curie, Oddział w Krakowie,, Krakow, , Poland
Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny, Lodz, , Poland
Oddzial Chemioterapii ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, , Poland
Klinika Onkologii, Oddzial Chemioterapii Akademii Medycznej w Poznaniu, Poznan, , Poland
SPZOZ Wojewodzki Szpital Specjalistyczny Nr 3, Oddzial Onkologii, Rybnik, , Poland
Wojewodzki Szpital Zespolony, Oddzial Onkologii Klinicznej, Torun, , Poland
Wojskowy Instytut Medyczny; Klinika Onkologii Centralnego Szpitala Klinicznego MON, Warszawa, , Poland
Centralny Szpital Kliniczny MSWiA, Klinika Onkologii, Hematologii i Chorob Wewnetrznych, Warszawa, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworów Narządów Płciowych Kobiecych, Warszawa, , Poland
Hospital Germans Trias y Pujol, Badalona, , Spain
Hospital Vall d'Hebrón, Servicio de Oncologia, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia, Barcelona, , Spain
Hospital Reina Sofia, Córdoba, , Spain
Hospital de Elche, Servico de Oncologia, Elche, , Spain
Instituto Catalán de Oncología - Hospital Universitari de Girona "Dr. Josep Trueta". Oncologia Medica, Girona, , Spain
Hospital Virgen de las Nieves, Granada, , Spain
Hospital Juan Ramón Jiménez de Huelva, Huelva, , Spain
Complejo Hospitalario de Jaén, Jaen, , Spain
Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica, La Coruna, , Spain
Hospital Universitario Arnau de Vilanova, Servicio de Oncologia, Lerida, , Spain
MD Anderson Internacional Espana, Madrid, , Spain
Hospital Clinico San Carlos, Servicio de Oncología Medica, Madrid, , Spain
Hospital de Mataró, Mataró, , Spain
Hospital Clinico de Malaga. Servicio de Oncologia, Málaga, , Spain
Hospital Central de Asturias, Oviedo, , Spain
Hospital Son Llatzer, Palma de Mallorca, , Spain
Hospital Son Dureta, Servicio de Oncología, Palma de Mallorca, , Spain
Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Name: Jacobus Pfisterer, MD
Affiliation: AGO-OVAR, Ovarian Cancer Study Group, Germany; Ubbo-Emmius-Klinik gGmbH Aurich, Germany
Role: STUDY_CHAIR
Name: Paul Sabbatini, MD
Affiliation: Memorial Sloan-Kettering Cancer Centre- NY
Role: PRINCIPAL_INVESTIGATOR
Name: Jonathan Berek, MD
Affiliation: COGI (Cooperative Ovarian Cancer Group for Immunotherapy); Dept Obstetrics and Gynecology, Stanford CA
Role: PRINCIPAL_INVESTIGATOR
Name: Giovanni Scambia, MD
Affiliation: Universtita' Cattolica del Sacro Cuore, Dipartimento di Oncologia - Roma, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Casado, MD
Affiliation: Hospital Clinico San Carlos, Servicio de Oncología Medica - Madrid, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Anna Pluzanska, MD
Affiliation: Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny - Lodz, Poland
Role: PRINCIPAL_INVESTIGATOR
Name: Karel Cwiertka, MD
Affiliation: Onkologická klinika Fakultni Nemocnice Olomouc, Czech Republic
Role: PRINCIPAL_INVESTIGATOR
Name: Tamás Pintér, MD
Affiliation: Petz Aladar Megyei Oktató Kórház, Onkoradiológia - Győr, Hungary
Role: PRINCIPAL_INVESTIGATOR
Name: Eric Pujade-Lauraine, MD
Affiliation: Hôpital Hotel Dieu - Paris, France
Role: PRINCIPAL_INVESTIGATOR