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

NCT ID: NCT00103545

Last Updated: 2006-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer Fallopian Tube Neoplasms Peritoneal Neoplasms

Keywords

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Ovarian Cancer ACA 125 6 or 9 vaccinations immune response Fallopian tube cancer Peritoneal cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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ACA 125

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AGO Study Group

OTHER

Sponsor Role lead

Principal Investigators

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Jacobus Pfisterer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

AGO Study Group

Locations

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Clinic for Gynecology and Gyn. Oncology, Humboldt University

Berlin, , Germany

Site Status

University Clinic Carl Gustav Carus, Gynecological hospital

Dresden, , Germany

Site Status

Gynecologic Hospital

Düsseldorf, , Germany

Site Status

University Gynecologic Hospital

Essen, , Germany

Site Status

University Gynecologic Hospital

Frankfurt, , Germany

Site Status

Gynecologic Clinic of the Ernst-Moritz-Arndt-University

Greifswald, , Germany

Site Status

University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics

Kiel, , Germany

Site Status

Otto-von-Guericke University, University Gynecological Hospital

Magdeburg, , Germany

Site Status

Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology

Marburg, , Germany

Site Status

University Gynecological Hospital

Ulm, , Germany

Site Status

Clinic for Gnyecology and gyn. Oncology HSK

Wiesbaden, , Germany

Site Status

Countries

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Germany

References

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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):1568-77. doi: 10.1093/annonc/mdl357.

Reference Type BACKGROUND
PMID: 17005631 (View on PubMed)

Related Links

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http://www.ago-ovar.de

Information on studies of the AGO-OVAR on Ovarian cancer

Other Identifiers

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AGO-OVAR 2.8

Identifier Type: -

Identifier Source: org_study_id