Use of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response - Full Text View

Sponsored by:	AGO Ovarian Cancer Study Group
Information provided by:	AGO Ovarian Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00103545

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 I Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

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

Further study details as provided by AGO Ovarian Cancer 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

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

Locations

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

Sponsors and Collaborators

AGO Ovarian Cancer Study Group

Investigators

Principal Investigator:

Jacobus Pfisterer, Prof. Dr.

AGO Ovarian Cancer Study Group

More Information

Additional Information:

Information on studies of the AGO-OVAR on Ovarian cancer This link exits the ClinicalTrials.gov site

Publications:

Pfisterer J, du Bois A, Sehouli J, Loibl S, Reinartz S, Reuss A, Canzler U, Belau A, Jackisch C, Kimmig R, Wollschlaeger K, Heilmann V, Hilpert F. The anti-idiotypic antibody abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR. Ann Oncol. 2006 Oct;17(10):1568-1577.

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

Keywords provided by AGO Ovarian Cancer Study Group:

Ovarian Cancer
ACA 125
6 or 9 vaccinations

immune response
Fallopian tube cancer
Peritoneal cancer

Study placed in the following topic categories:

Fallopian Tube Cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Abdominal Neoplasms
Fallopian Tube Neoplasms

Recurrence
Fallopian Tube Diseases
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Abdominal Neoplasms
Fallopian Tube Neoplasms

Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009