Status:
COMPLETED
Use of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response
Lead Sponsor:
AGO Study Group
Conditions:
Ovarian Cancer
Fallopian Tube Neoplasms
Eligibility:
FEMALE
Phase:
PHASE1
PHASE2
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 clin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00103545
Start Date
July 1 2003
End Date
August 1 2004
Last Update
October 2 2006
Active Locations (11)
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1
Clinic for Gynecology and Gyn. Oncology, Humboldt University
Berlin, Germany, 10117
2
University Clinic Carl Gustav Carus, Gynecological hospital
Dresden, Germany, 01307
3
Gynecologic Hospital
Düsseldorf, Germany, 40217
4
University Gynecologic Hospital
Essen, Germany, 45122