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Sponsored by: |
Menarini Group |
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Information provided by: | Menarini Group |
ClinicalTrials.gov Identifier: | NCT00418574 |
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.
Condition | Intervention | Phase |
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Ovarian Cancer |
Biological: Abagovomab |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 870 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2015 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Abagovomab
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Biological: Abagovomab
2 mg/ml SC (subcutaneously)
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B: Placebo Comparator |
Biological: Abagovomab
2 mg/ml SC (subcutaneously)
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At a maximum of 12 weeks after the last cycle of first line standard platinum/taxane IV or IP chemotherapy, patients must fulfill all the following inclusion criteria:
Adequate hematologic, renal and hepatic function:
Exclusion Criteria:
Patients are ineligible to participate in the study, if any of the following criteria are present:
Study Chair: | Jacobus Pfisterer, MD | AGO-OVAR, Ovarian Cancer Study Group, Germany; Ubbo-Emmius-Klinik gGmbH Aurich, Germany |
Principal Investigator: | Paul Sabbatini, MD | Memorial Sloan-Kettering Cancer Centre- NY |
Principal Investigator: | Jonathan Berek, MD | COGI (Cooperative Ovarian Cancer Group for Immunotherapy); Dept Obstetrics and Gynecology, Stanford CA |
Principal Investigator: | Giovanni Scambia, MD | Universtita' Cattolica del Sacro Cuore, Dipartimento di Oncologia - Roma, Italy |
Principal Investigator: | Antonio Casado, MD | Hospital Clinico San Carlos, Servicio de Oncología Medica - Madrid, Spain |
Principal Investigator: | Anna Pluzanska, MD | Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny - Lodz, Poland |
Principal Investigator: | Karel Cwiertka, MD | Onkologická klinika Fakultni Nemocnice Olomouc, Czech Republic |
Principal Investigator: | Tamás Pintér, MD | Petz Aladar Megyei Oktató Kórház, Onkoradiológia - Győr, Hungary |
Principal Investigator: | Eric Pujade-Lauraine, MD | Hôpital Hotel Dieu - Paris, France |
Responsible Party: | Menarini Group ( Menarini Group ) |
Study ID Numbers: | ABA-01, AGO Study Code: AGO-OVAR 10, EUDRACT No: 2006-0062801-30 |
Study First Received: | January 4, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00418574 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; Germany: Paul-Ehrlich-Institut; Germany: Ethics Commission; Belgium: Directorate general for the protection of Public health: Medicines; Belgium: Institutional Review Board; Italy: Ethics Committee; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Spain: Spanish Agency of Medicines; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Ovarian cancer Abagovomab |
Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases |
Urogenital Neoplasms Endocrinopathy Ovarian Diseases Ovarian epithelial cancer Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |