Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients
NCT ID: NCT00418574
Last Updated: 2011-11-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
888 participants
INTERVENTIONAL
2006-12-31
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Abagovomab
Abagovomab
2 mg/ml SC (subcutaneously)
Placebo
Placebo
2 mg/ml SC (subcutaneously)
Interventions
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Abagovomab
2 mg/ml SC (subcutaneously)
Placebo
2 mg/ml SC (subcutaneously)
Eligibility Criteria
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Inclusion Criteria
* 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 \</= 1.5 \* ULN (Upper Limit of Normal);
* Bilirubin \</= 1.5 \* ULN; AST, ALT, AP \</= 2.5 \* ULN.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \</= 2.
Exclusion Criteria
* any other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in situ, within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy;
* known active autoimmune disease requiring chronic treatment with immunosuppressive agents (e.g., rheumatoid arthritis, ulcerative colitis, etc.);
* known immune deficiency (e.g. HIV, hypogammaglobulinemia, etc.);
* known infection with hepatitis B, or hepatitis C;
* history of recent myocardial infarction (\</= 6 months) or decompensated heart failure (New York Heart Association - NYHA class \>/= 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.
18 Years
FEMALE
No
Sponsors
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Menarini Group
INDUSTRY
Responsible Party
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Principal Investigators
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Jacobus Pfisterer, MD
Role: STUDY_CHAIR
AGO-OVAR, Ovarian Cancer Study Group, Germany; Ubbo-Emmius-Klinik gGmbH Aurich, Germany
Paul Sabbatini, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan-Kettering Cancer Centre- NY
Jonathan Berek, MD
Role: PRINCIPAL_INVESTIGATOR
COGI (Cooperative Ovarian Cancer Group for Immunotherapy); Dept Obstetrics and Gynecology, Stanford CA
Giovanni Scambia, MD
Role: PRINCIPAL_INVESTIGATOR
Universtita' Cattolica del Sacro Cuore, Dipartimento di Oncologia - Roma, Italy
Antonio Casado, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico San Carlos, Servicio de Oncología Medica - Madrid, Spain
Anna Pluzanska, MD
Role: PRINCIPAL_INVESTIGATOR
Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny - Lodz, Poland
Karel Cwiertka, MD
Role: PRINCIPAL_INVESTIGATOR
Onkologická klinika Fakultni Nemocnice Olomouc, Czech Republic
Tamás Pintér, MD
Role: PRINCIPAL_INVESTIGATOR
Petz Aladar Megyei Oktató Kórház, Onkoradiológia - Győr, Hungary
Eric Pujade-Lauraine, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Hotel Dieu - Paris, France
Locations
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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
St Louis, Missouri, United States
The Cancer Care Center
St 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
Brussels, , Belgium
Universitair Ziekenhuis Gent Medische Oncologie 4B-Z
Ghent, , 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, , Czechia
MOU Zluty Kopec
Brno, , Czechia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke
Liberec, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni Nemocnice Ostrava
Ostrava, , Czechia
Krajska nemocnice
Pardubice, , Czechia
Gynekologicko-porodnicka klinika FN Plzen
Pilsen, , Czechia
Fakultni nemocnice Královské Vinohrady
Prague, , Czechia
Vseobecna Fakultni Nemocnice
Prague, , Czechia
Fakultni nemocnice Bulovka
Prague, , Czechia
Krajska nemocnice T. Bati
Zlín, , Czechia
Institut Bergonié
Bordeaux, , France
Centre Jean Bernard
Le Mans, , France
Centre Catherine de Sienne
Nantes, , 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
Klinikum der Universität zu Köln
Cologne, , 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 im Breisgau, , Germany
Universitätsklinikum
Göttingen, , Germany
Klinikum der Ernst-Moritz-Universität
Greifswald, , Germany
Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät
Halle, , Germany
Universitätskrankenhaus Hamburg-Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Jena
Jena, , Germany
St. Vincentius Kliniken AG
Karlsruhe, , Germany
Klinikum Kassel
Kassel, , Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, , 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
Tatabánya, , 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
Florence, , Italy
Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica
Genova, , Italy
Istituto Nazionale dei Tumori di Milano
Milan, , Italy
Istituto Europeo di Oncologia - Divisione di Ginecologia
Milan, , 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 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
Częstochowa, , 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
Warsaw, , Poland
Centralny Szpital Kliniczny MSWiA, Klinika Onkologii, Hematologii i Chorob Wewnetrznych
Warsaw, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworów Narządów Płciowych Kobiecych
Warsaw, , Poland
Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica
A Coruña, , Spain
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
Jaén, , Spain
Hospital Universitario Arnau de Vilanova, Servicio de Oncologia
Lleida, , 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
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Countries
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References
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Reinartz S, Kohler S, Schlebusch H, Krista K, Giffels P, Renke K, Huober J, Mobus V, Kreienberg R, DuBois A, Sabbatini P, Wagner U. Vaccination of patients with advanced ovarian carcinoma with the anti-idiotype ACA125: immunological response and survival (phase Ib/II). Clin Cancer Res. 2004 Mar 1;10(5):1580-7. doi: 10.1158/1078-0432.ccr-03-0056.
Wagner U, Kohler S, Reinartz S, Giffels P, Huober J, Renke K, Schlebusch H, Biersack HJ, Mobus V, Kreienberg R, Bauknecht T, Krebs D, Wallwiener D. Immunological consolidation of ovarian carcinoma recurrences with monoclonal anti-idiotype antibody ACA125: immune responses and survival in palliative treatment. See The biology behind: K. A. Foon and M. Bhattacharya-Chatterjee, Are solid tumor anti-idiotype vaccines ready for prime time? Clin. Cancer Res., 7:1112-1115, 2001. Clin Cancer Res. 2001 May;7(5):1154-62.
Pfisterer J, du Bois A, Sehouli J, Loibl S, Reinartz S, Reuss A, Canzler U, Belau A, Jackisch C, Kimmig R, Wollschlaeger K, Heilmann V, Hilpert F. The anti-idiotypic antibody abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR. Ann Oncol. 2006 Oct;17(10):1568-77. doi: 10.1093/annonc/mdl357.
Sabbatini P, Dupont J, Aghajanian C, Derosa F, Poynor E, Anderson S, Hensley M, Livingston P, Iasonos A, Spriggs D, McGuire W, Reinartz S, Schneider S, Grande C, Lele S, Rodabaugh K, Kepner J, Ferrone S, Odunsi K. Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Clin Cancer Res. 2006 Sep 15;12(18):5503-10. doi: 10.1158/1078-0432.CCR-05-2670.
Buzzonetti A, Fossati M, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological response induced by abagovomab as a maintenance therapy in patients with epithelial ovarian cancer: relationship with survival-a substudy of the MIMOSA trial. Cancer Immunol Immunother. 2014 Oct;63(10):1037-45. doi: 10.1007/s00262-014-1569-0. Epub 2014 Jun 21.
Sabbatini P, Harter P, Scambia G, Sehouli J, Meier W, Wimberger P, Baumann KH, Kurzeder C, Schmalfeldt B, Cibula D, Bidzinski M, Casado A, Martoni A, Colombo N, Holloway RW, Selvaggi L, Li A, del Campo J, Cwiertka K, Pinter T, Vermorken JB, Pujade-Lauraine E, Scartoni S, Bertolotti M, Simonelli C, Capriati A, Maggi CA, Berek JS, Pfisterer J. Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO--the MIMOSA study. J Clin Oncol. 2013 Apr 20;31(12):1554-61. doi: 10.1200/JCO.2012.46.4057. Epub 2013 Mar 11.
Other Identifiers
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AGO-OVAR 10
Identifier Type: OTHER
Identifier Source: secondary_id
2006-002801-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ABA-01
Identifier Type: -
Identifier Source: org_study_id