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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103545
Recruitment Status : Completed
First Posted : February 11, 2005
Last Update Posted : October 2, 2006
Information provided by:
AGO Study Group

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Neoplasms Peritoneal Neoplasms Biological: ACA 125 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2003
Study Completion Date : August 2004

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00103545

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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
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Principal Investigator: Jacobus Pfisterer, Prof. Dr. AGO Study Group
Additional Information:
Layout table for additonal information Identifier: NCT00103545    
Other Study ID Numbers: AGO-OVAR 2.8
First Posted: February 11, 2005    Key Record Dates
Last Update Posted: October 2, 2006
Last Verified: February 2006
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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents