Back to resultsUse of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response
Primary Purpose
Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasms
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
ACA 125
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Cancer focused on measuring Ovarian Cancer, ACA 125, 6 or 9 vaccinations, immune response, Fallopian tube cancer, Peritoneal cancer
Eligibility 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
Sites / Locations
- Clinic for Gynecology and Gyn. Oncology, Humboldt University
- University Clinic Carl Gustav Carus, Gynecological hospital
- Gynecologic Hospital
- University Gynecologic Hospital
- University Gynecologic Hospital
- Gynecologic Clinic of the Ernst-Moritz-Arndt-University
- University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
- Otto-von-Guericke University, University Gynecological Hospital
- Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology
- University Gynecological Hospital
- Clinic for Gnyecology and gyn. Oncology HSK
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00103545
Brief Title
Use of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response
Official Title
A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AGO Study Group
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasms
Keywords
Ovarian Cancer, ACA 125, 6 or 9 vaccinations, immune response, Fallopian tube cancer, Peritoneal cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
ACA 125
Primary Outcome Measure Information:
Title
Safety, feasibility and tolerability
Title
The primary endpoint is drop-out due to toxicity as the overall measure of feasibility
Secondary Outcome Measure Information:
Title
Duration and strength of the immune response induced by ACA 125 vaccination
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacobus Pfisterer, Prof. Dr.
Organizational Affiliation
AGO Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Gynecology and Gyn. Oncology, Humboldt University
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
University Clinic Carl Gustav Carus, Gynecological hospital
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Gynecologic Hospital
City
Duesseldorf
ZIP/Postal Code
40217
Country
Germany
Facility Name
University Gynecologic Hospital
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
University Gynecologic Hospital
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Gynecologic Clinic of the Ernst-Moritz-Arndt-University
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
Facility Name
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Otto-von-Guericke University, University Gynecological Hospital
City
Magdeburg
ZIP/Postal Code
39108
Country
Germany
Facility Name
Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
University Gynecological Hospital
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Clinic for Gnyecology and gyn. Oncology HSK
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17005631
Citation
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.
Results Reference
background
Links:
URL
http://www.ago-ovar.de
Description
Information on studies of the AGO-OVAR on Ovarian cancer
Learn more about this trial
Use of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response
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