Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients
- Conditions
- Ovarian Cancer
- Interventions
- Biological: AbagovomabBiological: Placebo
- Registration Number
- NCT00418574
- Lead Sponsor
- Menarini Group
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 888
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 </= 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.
Patients are ineligible to participate in the study, if any of the following criteria are present:
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abagovomab Abagovomab - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC) Every 12 weeks up to recurrence or up to 3 months after last administered dose The Recurrence free survival correspond to the time from date of randomization to documented disease recurrence or death. Disease recurrence is defined as the appearance of any lesion or development of tumor-related symptoms evaluated by medical examination and must be confirmed by a documented CT scan.
- Secondary Outcome Measures
Name Time Method Overall Survival 2 years 2 years survival rate
Safety 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 was analyzed in all patients who received at least 1 dose administration.
Adverse event (AE) are defined as events which started on or after the first dose of study medication and on or before the date of the final study visit, or within 12 weeks of the last dose if the final study visit was not performed.Time Course of Immunoresponse 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) Time course of immunologic parameters (anti-anti-idiotypic antibody - Ab3) will be assessed in all patients, by comparing levels at baseline (week 0), at week 10 after first dose administration and at end of treatment (at week 4 or week 12 after the last administered dose, as appropriate).
Trial Locations
- Locations (147)
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Curtis and Elizabeth Anderson Cancer Institute
🇺🇸Savannah, Georgia, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square
🇺🇸Baltimore, Maryland, United States
University of Miami
🇺🇸Miami, Florida, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Women's Cancer Center
🇺🇸Las Vegas, Nevada, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Nemocnice Ceske Budejovice, a.s.
🇨🇿Ceske Budejovice, Czech Republic
Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke
🇨🇿Liberec, Czech Republic
MOU Zluty Kopec
🇨🇿Brno, Czech Republic
Fakultni Nemocnice Ostrava
🇨🇿Ostrava, Czech Republic
Krajska nemocnice T. Bati
🇨🇿Zlin, Czech Republic
Pécsi Tudományegyetem, ÁOK Szülészeti és Nőgyógyászati Klinika
🇭🇺Pécs, Hungary
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
Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia
🇭🇺Budapest, Hungary
Fakultni nemocnice Brno
🇨🇿Brno, Czech Republic
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Králové, Czech Republic
Krajska nemocnice
🇨🇿Pardubice, Czech Republic
Vseobecna Fakultni Nemocnice
🇨🇿Praha 2, Czech Republic
Fakultni nemocnice Královské Vinohrady
🇨🇿Praha, Czech Republic
Oddzial Onkologii Wojewódzki Szpital Specjalistyczny
🇵🇱Czestochowa, Poland
Wojewodzkie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
🇵🇱Gdansk, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny Nr 3, Oddzial Onkologii
🇵🇱Rybnik, Poland
Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika
🇭🇺Budapest, Hungary
Komárom-Esztergom Megyei Onkormanyzat Szent Borbála Kórház, Szülészet-Nőgyógyászati Osztály
🇭🇺Tatabanya, Hungary
Wojewódzki Szpital Specjalistyczny Nr 4
🇵🇱Bytom, Poland
Klinika Onkologii, Oddzial Chemioterapii Akademii Medycznej w Poznaniu
🇵🇱Poznan, Poland
Wojewodzki Szpital Zespolony, Oddzial Onkologii Klinicznej
🇵🇱Torun, 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
University of Colorado
🇺🇸Denver, Colorado, United States
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Kórháza, Szülészet-Nőgyógyászati Osztály
🇭🇺Nyíregyháza, Hungary
Fakultni nemocnice Bulovka
🇨🇿Praha 8, Czech Republic
Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészetl es Nőgyógyászatl Klinika
🇭🇺Debrecen, Hungary
Petz Aladar Megyei Oktató Kórház, Onkoradiológia
🇭🇺Győr, Hungary
"Centrum Onkologii, Instytut im. M. Skłodowskiej-Curie, Oddział w Krakowie,
🇵🇱Krakow, Poland
Wojskowy Instytut Medyczny; Klinika Onkologii Centralnego Szpitala Klinicznego MON
🇵🇱Warszawa, Poland
Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika
🇭🇺Budapest, Hungary
Oncologia Medica Ospedale di Faenza - AUSL di Ravenna
🇮🇹Faenza, Italy
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Centre
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Centre Catherine de Sienne
🇫🇷Nantes Cedex, France
Women and Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Algemeen Stedelijk Ziekenhuis Aalst
🇧🇪Aalst, Belgium
The West Clinic
🇺🇸Memphis, Tennessee, United States
Centre Jean Bernard
🇫🇷Le Mans Cedex, France
Hôpital Hotel Dieu
🇫🇷Paris, France
Helios Kliniken GmbH, Klinikum Buch
🇩🇪Berlin, Germany
Universitair Ziekenhuis Gent Medische Oncologie 4B-Z
🇧🇪Gent, Belgium
Clinique Sainte Elizabeth
🇧🇪Namur, Belgium
AZ Sint Augustinus, Oncologisch Centrum GVA
🇧🇪Wilrijk, Belgium
Klinikum Bremen-Mitte gGmbH
🇩🇪Bremen, Germany
Charité - Campus Virchow Klinikum
🇩🇪Berlin, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
Kreisklinik Ebersberg gGmbH
🇩🇪Ebersberg, Germany
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
St.-Josefs-Hospital Cloppenburg
🇩🇪Cloppenburg, Germany
Klinikum Chemnitz GmbH
🇩🇪Chemnitz, Germany
Universitätsklinikum
🇩🇪Ulm, Germany
Klinikum der JWG Universität Frankfurt
🇩🇪Frankfurt, Germany
Evangelisches Krankenhaus
🇩🇪Düsseldorf, Germany
Universitätskrankenhaus Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Klinikum Kassel
🇩🇪Kassel, Germany
Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät
🇩🇪Halle/Saale, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Klinikum der Ernst-Moritz-Universität
🇩🇪Greifswald, Germany
St. Vincentius Kliniken AG
🇩🇪Karlsruhe, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
Klinikum der Universität zu Köln
🇩🇪Köln, Germany
Kreiskrankenhaus Leonberg
🇩🇪Leonberg, Germany
Vincenz-Krankenhaus
🇩🇪Limburg, Germany
Asklepios Klinik Lich
🇩🇪Lich, Germany
Krankenhaus St. Josef
🇩🇪Regensburg, Germany
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
Azienda Ospedaliera - Universitaria Careggi
🇮🇹Firenze, Italy
Istituto Europeo di Oncologia - Divisione di Ginecologia
🇮🇹Milano, Italy
Policlinico di Modena, Dipartimento di Oncologia ed Ematologia
🇮🇹Modena, Italy
Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica
🇮🇹Genova, Italy
Istituto Nazionale dei Tumori di Milano
🇮🇹Milano, 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
Dipartimento di Discipline Ginecologiche e Ostetriche - Universita degli Studi di Torino - Azienda ospedaliera O.I.R.M.-S'Anna
🇮🇹Torino, Italy
Policlinico Umberto I D.H. Oncologico Oncologia Medica
🇮🇹Roma, Italy
Dipartimento di Ginecologia ed Ostetricia Policlinico Universitario Gemelli
🇮🇹Roma, Italy
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
Instituto Catalán de Oncología - Hospital Universitari de Girona "Dr. Josep Trueta". Oncologia Medica
🇪🇸Girona, Spain
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Spain
Hospital Son Dureta, Servicio de Oncología
🇪🇸Palma de Mallorca, Spain
Vesalius Kraków
🇵🇱Krakow, Poland
Hospital de Elche, Servico de Oncologia
🇪🇸Elche, 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 Vall d'Hebrón, Servicio de Oncologia
🇪🇸Barcelona, Spain
Hospital Germans Trias y Pujol
🇪🇸Badalona, Spain
Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia
🇪🇸Barcelona, Spain
Hospital Reina Sofia
🇪🇸Córdoba, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaen, Spain
Hospital de Mataró
🇪🇸Mataró, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Wayne State University
🇺🇸Detroit, Michigan, United States
Hackensack University Medical Center, Obstetrics and Gynecology Oncology
🇺🇸Hackensack, New Jersey, United States
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Stanford University
🇺🇸Stanford, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
The Cancer Care Center
🇺🇸Saint Louis, Missouri, United States
Indiana University Cancer Pavilion
🇺🇸Indianapolis, Indiana, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
CHU de Liége (Sart Tilman)
🇧🇪Liège, Belgium
Gynekologicko-porodnicka klinika FN Plzen
🇨🇿Plzen, Czech Republic
Institut Bergonié
🇫🇷Bordeaux Cedex, France
Johannes-Gutenberg-Universität
🇩🇪Mainz, Germany
Städtisches Klinikum Magdeburg
🇩🇪Magdeburg, Germany
Klinik St. Marienstift
🇩🇪Magdeburg, Germany
Otto-von-Guericke-Universität
🇩🇪Magdeburg, 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
Hospital Juan Ramón Jiménez de Huelva
🇪🇸Huelva, Spain
Elblandkliniken Meißen-Radebeul GmbH
🇩🇪Radebeul, Germany
Klinikum Südstadt der Hansestadt Rostock
🇩🇪Rostock, Germany
r. Horst Schmidt Kliniken GmbH
🇩🇪Wiesbaden, Germany
Klinikum der Stadt Villingen-Schwenningen GmbH
🇩🇪Villingen-Schwenningen, Germany
St. Josefs-Hospital
🇩🇪Wiesbaden, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg
🇩🇪Wolfsburg, Germany
Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica
🇮🇹Napoli, Italy
Ospedale Casa Sollievo della Sofferenza - Unita' Operativa di Ostetricia e Ginecologia
🇮🇹San Giovanni Rotondo (FG), Italy
Hospital Clinico de Malaga. Servicio de Oncologia
🇪🇸Málaga, Spain
Hospital Clinico San Carlos, Servicio de Oncología Medica
🇪🇸Madrid, Spain