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

This study has been completed.
Sponsor:
Information provided by:
AGO Study Group
ClinicalTrials.gov Identifier:
NCT00103545
First received: February 10, 2005
Last updated: September 29, 2006
Last verified: February 2006
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Biological: ACA 125
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

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

Secondary Outcome Measures:
  • Duration and strength of the immune response induced by ACA 125 vaccination

Estimated Enrollment: 36
Study Start Date: July 2003
Estimated Study Completion Date: August 2004
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103545

Locations
Germany
Clinic for Gynecology and Gyn. Oncology, Humboldt University
Berlin, Germany, 10117
University Clinic Carl Gustav Carus, Gynecological hospital
Dresden, Germany, 01307
Gynecologic Hospital
Duesseldorf, Germany, 40217
University Gynecologic Hospital
Essen, Germany, 45122
University Gynecologic Hospital
Frankfurt, Germany, 60596
Gynecologic Clinic of the Ernst-Moritz-Arndt-University
Greifswald, Germany, 17487
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
Kiel, Germany, 24105
Otto-von-Guericke University, University Gynecological Hospital
Magdeburg, Germany, 39108
Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology
Marburg, Germany, 35033
University Gynecological Hospital
Ulm, Germany, 89075
Clinic for Gnyecology and gyn. Oncology HSK
Wiesbaden, Germany, 65199
Sponsors and Collaborators
AGO Study Group
Investigators
Principal Investigator: Jacobus Pfisterer, Prof. Dr. AGO Study Group
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00103545     History of Changes
Other Study ID Numbers: AGO-OVAR 2.8
Study First Received: February 10, 2005
Last Updated: September 29, 2006
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AGO Study Group:
Ovarian Cancer
ACA 125
6 or 9 vaccinations
immune response
Fallopian tube cancer
Peritoneal cancer

Additional relevant MeSH terms:
Neoplasms
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on July 20, 2014