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

NCT00418574 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 888

Last updated 2011-11-24

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Abagovomab

2 mg/ml SC (subcutaneously)

BIOLOGICAL

Placebo

2 mg/ml SC (subcutaneously)

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Jacobus Pfisterer, MD · AGO-OVAR, Ovarian Cancer Study Group, Germany; Ubbo-Emmius-Klinik gGmbH Aurich, Germany

  • Paul Sabbatini, MD · Memorial Sloan-Kettering Cancer Centre- NY

  • Jonathan Berek, MD · COGI (Cooperative Ovarian Cancer Group for Immunotherapy); Dept Obstetrics and Gynecology, Stanford CA

  • Giovanni Scambia, MD · Universtita' Cattolica del Sacro Cuore, Dipartimento di Oncologia - Roma, Italy

  • Antonio Casado, MD · Hospital Clinico San Carlos, Servicio de Oncología Medica - Madrid, Spain

  • Anna Pluzanska, MD · Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny - Lodz, Poland

  • Karel Cwiertka, MD · Onkologická klinika Fakultni Nemocnice Olomouc, Czech Republic

  • Tamás Pintér, MD · Petz Aladar Megyei Oktató Kórház, Onkoradiológia - Győr, Hungary

  • Eric Pujade-Lauraine, MD · Hôpital Hotel Dieu - Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00418574 on ClinicalTrials.gov