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NCT00103545 Clinical Trial

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

Ovarian Cancer Clinical Trial

Official title:
A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00103545
Other study ID # AGO-OVAR 2.8
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 10, 2005
Last updated September 29, 2006
Start date July 2003
Est. completion date August 2004

Study information
Verified date February 2006
Source AGO Study Group
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date August 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• ACA 125

Locations
Country Name City State
Germany Clinic for Gynecology and Gyn. Oncology, Humboldt University Berlin
Germany University Clinic Carl Gustav Carus, Gynecological hospital Dresden
Germany Gynecologic Hospital Duesseldorf
Germany University Gynecologic Hospital Essen
Germany University Gynecologic Hospital Frankfurt
Germany Gynecologic Clinic of the Ernst-Moritz-Arndt-University Greifswald
Germany University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics Kiel
Germany Otto-von-Guericke University, University Gynecological Hospital Magdeburg
Germany Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology Marburg
Germany University Gynecological Hospital Ulm
Germany Clinic for Gnyecology and gyn. Oncology HSK Wiesbaden

Sponsors (1)
Lead Sponsor Collaborator
AGO Study Group

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety, feasibility and tolerability
Primary The primary endpoint is drop-out due to toxicity as the overall measure of feasibility
Secondary Duration and strength of the immune response induced by ACA 125 vaccination
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