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

Phase 1

Completed

• Conditions: Ovarian Cancer; Fallopian Tube Neoplasms; Peritoneal Neoplasms

• Registration Number: NCT00103545
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-07
• Study Completion: 2004-08
• Study First Submitted: 2005-02-10
• Study First Submitted QC: 2005-02-10
• Study First Posted: 2005-02-11
• Status Verified: 2006-02
• Last Update Submitted: 2006-09-29
• Last Update Posted: 2006-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration and strength of the immune response induced by ACA 125 vaccination

Trial Locations

Locations (10)

Clinic for Gnyecology and gyn. Oncology HSK; 🇩🇪 Wiesbaden, Germany

University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics; 🇩🇪 Kiel, Germany

Clinic for Gynecology and Gyn. Oncology, Humboldt University; 🇩🇪 Berlin, Germany

University Clinic Carl Gustav Carus, Gynecological hospital; 🇩🇪 Dresden, Germany

University Gynecological Hospital; 🇩🇪 Ulm, Germany

Otto-von-Guericke University, University Gynecological Hospital; 🇩🇪 Magdeburg, Germany

Gynecologic Hospital; 🇩🇪 Duesseldorf, Germany

University Gynecologic Hospital; 🇩🇪 Frankfurt, Germany

Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology; 🇩🇪 Marburg, Germany

Gynecologic Clinic of the Ernst-Moritz-Arndt-University; 🇩🇪 Greifswald, Germany