Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients

Status: Terminated
Study State Date: December 2006
Primary Completion Date: Actual December 2010
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Phase: Phase 2/Phase 3
Why Stopped:  No benefit on primary end point (RFS); no rationale to collect survival data

Sponsor(s):
Menarini Group
 
Information By: Menarini Group
Trial Identifier: NCT00418574
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

Description:  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.

+ Additional Objectives Detail

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.



Accepts Healthy Volunteers?: No
Enrollment: 888 Actual
Minimum Age: 18 Years
Maximum Age: N/A
Gender(s): Female
Additional Criteria:  Inclusion Criteria: At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane intravenous (IV) or intraperitoneal (IP) chemotherapy, patients must fulfill all the following inclusion criteria: - Age >/= 18 years; - Properly executed written informed consent; - History of histological and CA125 (> 35 U/ml) confirmed diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; - History of debulking surgery and 6-8 cycles of standard platinum/taxane based non-investigational IV-IP chemotherapy; - Complete clinical response defined as: - Normal physical examination; - No symptoms suggestive of persistent cancer; - No definite evidence of disease by computed tomography (CT) of the abdomen and pelvis within the previous 4 weeks; - Negative chest x-ray (or chest CT scan) within the previous 4 weeks; - Serum CA125 within the normal laboratory range. - Adequate hematologic, renal and hepatic function: - Absolute Neutrophil Count (ANC) >/=1.5 * 109/l; - Platelets >/= 75 * 109/l; - Haemoglobin >/= 6.2 mmol/l (>9.9 g/dl); - Serum creatinine /= III); - previous or concomitant use of any anti-cancer therapy other than the platinum-taxane based 1st line chemotherapy for ovarian cancer; any maintenance or consolidation therapy is not permitted after completion of standard front line chemotherapy. - concomitant use of any other investigational agent; - any prior investigational anti-cancer vaccine or monoclonal antibody; - known allergy to murine proteins; - any significant medical or psychiatric condition, drug or alcohol abuse that might prevent the patient from complying with all study procedures; - clinically significant active infection; - concomitant use of any immunosuppressive agent (e.g., steroids, cyclosporin, etc.); - major surgery within the previous 2 weeks; - radiotherapy within the previous 4 weeks; - any significant toxicity from prior chemotherapy; - unreliability or inability to follow protocol requirements; - potentially childbearing and not willing to use adequate contraceptive methods throughout the entire study period; - pregnancy.

Conditions:
Ovarian Cancer
Ovarian Neoplasms
Interventions:
Biological: Abagovomab
Biological: Placebo
 
Primary Outcome Measures:
Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)
Time Frame: Every 12 weeks up to recurrence or up to 3 months after last administered dose
Safety Issue: No

 
Secondary Outcome Measures:
Overall Survival
Time Frame: 2 years
Safety Issue: No

Safety
Time Frame: Along treatment administration and up to double blind observation period. i.e. for each patient after the first dose administration till the f inal study visit, or within 12 weeks of the last dose
Safety Issue: Yes

Time Course of Immunoresponse
Time Frame: at baseline, at week 10 after first dose administration and at final study visit (at week 4 or week 12 after the last administered dose, as appropriate)
Safety Issue: No

 
Patient Groups:
Assigned Interventions:

Abagovomab: Experimental
Biological: Abagovomab
2 mg/ml SC (subcutaneously)

 
Placebo: Placebo Comparator
Biological: Placebo
2 mg/ml SC (subcutaneously)

 


Investigators:
Principal Investigator: Anna Pluzanska, MD, Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny - Lodz, Poland
Principal Investigator: Antonio Casado, MD, Hospital Clinico San Carlos, Servicio de Oncología Medica - Madrid, Spain
Principal Investigator: Eric Pujade-Lauraine, MD, Hôpital Hotel Dieu - Paris, France
Principal Investigator: Giovanni Scambia, MD, Universtita' Cattolica del Sacro Cuore, Dipartimento di Oncologia - Roma, Italy
Study Chair: Jacobus Pfisterer, MD, AGO-OVAR, Ovarian Cancer Study Group, Germany; Ubbo-Emmius-Klinik gGmbH Aurich, Germany
Principal Investigator: Jonathan Berek, MD, COGI (Cooperative Ovarian Cancer Group for Immunotherapy); Dept Obstetrics and Gynecology, Stanford CA
Principal Investigator: Karel Cwiertka, MD, Onkologická klinika Fakultni Nemocnice Olomouc, Czech Republic
Principal Investigator: Paul Sabbatini, MD, Memorial Sloan-Kettering Cancer Centre- NY
Principal Investigator: Tamás Pintér, MD, Petz Aladar Megyei Oktató Kórház, Onkoradiológia - Győr, Hungary


Study Locations:
+ Show All 150 Study Locations


United States, California
University of California, Los Angeles (UCLA) 
Los Angeles, California, United States

Cedars-Sinai Medical Center 
Los Angeles, California, United States

Stanford University 
Stanford, California, United States



United States, Colorado
University of Colorado 
Denver, Colorado, United States



United States, Connecticut
University of Connecticut Health Center 
Farmington, Connecticut, United States



United States, Florida
University of Miami 
Miami, Florida, United States

Florida Hospital Cancer Institute 
Orlando, Florida, United States



United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute 
Savannah, Georgia, United States



United States, Indiana
Indiana University Cancer Pavilion 
Indianapolis, Indiana, United States



United States, Maryland
Harry and Jeanette Weinberg Cancer Institute at Franklin Square 
Baltimore, Maryland, United States



United States, Massachusetts
Beth Israel Deaconess Medical Center 
Boston, Massachusetts, United States



United States, Michigan
Wayne State University 
Detroit, Michigan, United States



United States, Missouri
The Cancer Care Center 
Saint Louis, Missouri, United States

Washington University 
Saint Louis, Missouri, United States



United States, Nevada
Women's Cancer Center 
Las Vegas, Nevada, United States



United States, New Jersey
Hackensack University Medical Center, Obstetrics and Gynecology Oncology 
Hackensack, New Jersey, United States



United States, New York
Roswell Park Cancer Institute 
Buffalo, New York, United States

Memorial Sloan-Kettering Cancer Centre 
New York, New York, United States



United States, North Carolina
Duke University Medical Center 
Durham, North Carolina, United States



United States, Pennsylvania
University of Pittsburgh 
Pittsburgh, Pennsylvania, United States



United States, Rhode Island
Women and Infants Hospital of Rhode Island 
Providence, Rhode Island, United States



United States, Tennessee
The West Clinic 
Memphis, Tennessee, United States



Belgium
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



Czech Republic
MOU Zluty Kopec 
Brno, Czech Republic

Fakultni nemocnice Brno 
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

Fakultni nemocnice Královské Vinohrady 
Praha, Czech Republic

Vseobecna Fakultni Nemocnice 
Praha 2, Czech Republic

Fakultni nemocnice Bulovka 
Praha 8, Czech Republic

Krajska nemocnice T. Bati 
Zlin, Czech Republic



France
Institut Bergonié 
Bordeaux Cedex, France

Centre Jean Bernard 
Le Mans Cedex, France

Centre Catherine de Sienne 
Nantes Cedex, France

Hôpital Hotel Dieu 
Paris, France



Germany
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

Otto-von-Guericke-Universität 
Magdeburg, Germany

Städtisches Klinikum Magdeburg 
Magdeburg, Germany

Klinik St. Marienstift 
Magdeburg, Germany

Johannes-Gutenberg-Universität 
Mainz, Germany

Universitätsklinikum Gießen u. Marburg 
Marburg, Germany

Klinikum rechts der Isar 
München, Germany

Klinikum Großhadern 
München, Germany

Klinikum der Universität München-Innenstadt 
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

r. Horst Schmidt Kliniken GmbH 
Wiesbaden, Germany

St. Josefs-Hospital 
Wiesbaden, Germany

Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg 
Wolfsburg, Germany



Hungary
Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika 
Budapest, Hungary

Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika 
Budapest, Hungary

Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia 
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



Italy
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



Poland
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



Spain
Hospital Germans Trias y Pujol 
Badalona, Spain

Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia 
Barcelona, Spain

Hospital Vall d'Hebrón, 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 Dureta, Servicio de Oncología 
Palma de Mallorca, Spain

Hospital Son Llatzer 
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

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