Use of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response

September 29, 2006 updated by: AGO Study Group

A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

The purpose of this study is to use an immunologic approach following the treatment for recurrent disease in patients with ovarian, fallopian tube, or peritoneal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with epithelial ovarian, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Many patients respond to additional cytotoxic treatment with partial or complete responses, yet approximately 100% of these patients will ultimately progress. Novel consolidation strategies following treatment for recurrent disease are needed and an immunologic approach is an attractive option.

Study Type

Interventional

Enrollment

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Clinic for Gynecology and Gyn. Oncology, Humboldt University
      • Dresden, Germany, 01307
        • University Clinic Carl Gustav Carus, Gynecological hospital
      • Duesseldorf, Germany, 40217
        • Gynecologic Hospital
      • Essen, Germany, 45122
        • University Gynecologic Hospital
      • Frankfurt, Germany, 60596
        • University Gynecologic Hospital
      • Greifswald, Germany, 17487
        • Gynecologic Clinic of the Ernst-Moritz-Arndt-University
      • Kiel, Germany, 24105
        • University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
      • Magdeburg, Germany, 39108
        • Otto-von-Guericke University, University Gynecological Hospital
      • Marburg, Germany, 35033
        • Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology
      • Ulm, Germany, 89075
        • University Gynecological Hospital
      • Wiesbaden, Germany, 65199
        • Clinic for Gnyecology and gyn. Oncology HSK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, stages I-IV. These patients must have received initial surgery and chemotherapy with at least one platinum based chemotherapy regimen.
  • Patients must have relapsed and now have completed chemotherapy for recurrent disease within the last 6 weeks.
  • Eligible patients may have asymptomatic residual measurable disease on CT scan, and/or may have an elevated CA-125, or may be in complete clinical remission.
  • Patients must have adequate hematologic, renal and hepatic functions.

Exclusion Criteria:

  • Patients with any other active malignancy concomitantly
  • Patients within 3 weeks of prior cytotoxic or investigational chemotherapy
  • Patients within 4 weeks of prior radiotherapy
  • Patients within 6 weeks of prior immunotherapy
  • Patients who have received any prior anti-cancer vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety, feasibility and tolerability
The primary endpoint is drop-out due to toxicity as the overall measure of feasibility

Secondary Outcome Measures

Outcome Measure
Duration and strength of the immune response induced by ACA 125 vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGO Study Group

Investigators

  • Principal Investigator: Jacobus Pfisterer, Prof. Dr., AGO Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion

August 1, 2004

Study Registration Dates

First Submitted

February 10, 2005

First Submitted That Met QC Criteria

February 10, 2005

First Posted (Estimate)

February 11, 2005

Study Record Updates

Last Update Posted (Estimate)

October 2, 2006

Last Update Submitted That Met QC Criteria

September 29, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGO-OVAR 2.8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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