Use of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response
This study has been completed.
Sponsor:
AGO Study Group
Information provided by:
AGO Study Group
ClinicalTrials.gov Identifier:
NCT00103545
First received: February 10, 2005
Last updated: September 29, 2006
Last verified: February 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Fallopian Tube Neoplasms Peritoneal Neoplasms |
Biological: ACA 125 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer |
Resource links provided by NLM:
Further study details as provided by AGO Study Group:
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
| Estimated Enrollment: | 36 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | August 2004 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103545
Locations
| Germany | |
| Clinic for Gynecology and Gyn. Oncology, Humboldt University | |
| Berlin, Germany, 10117 | |
| University Clinic Carl Gustav Carus, Gynecological hospital | |
| Dresden, Germany, 01307 | |
| Gynecologic Hospital | |
| Duesseldorf, Germany, 40217 | |
| University Gynecologic Hospital | |
| Essen, Germany, 45122 | |
| University Gynecologic Hospital | |
| Frankfurt, Germany, 60596 | |
| Gynecologic Clinic of the Ernst-Moritz-Arndt-University | |
| Greifswald, Germany, 17487 | |
| University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics | |
| Kiel, Germany, 24105 | |
| Otto-von-Guericke University, University Gynecological Hospital | |
| Magdeburg, Germany, 39108 | |
| Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology | |
| Marburg, Germany, 35033 | |
| University Gynecological Hospital | |
| Ulm, Germany, 89075 | |
| Clinic for Gnyecology and gyn. Oncology HSK | |
| Wiesbaden, Germany, 65199 | |
Sponsors and Collaborators
AGO Study Group
Investigators
| Principal Investigator: | Jacobus Pfisterer, Prof. Dr. | AGO Study Group |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00103545 History of Changes |
| Other Study ID Numbers: | AGO-OVAR 2.8 |
| Study First Received: | February 10, 2005 |
| Last Updated: | September 29, 2006 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by AGO Study Group:
|
Ovarian Cancer ACA 125 6 or 9 vaccinations |
immune response Fallopian tube cancer Peritoneal cancer |
Additional relevant MeSH terms:
|
Neoplasms Fallopian Tube Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Fallopian Tube Diseases Adnexal Diseases |
Genital Diseases, Female Endocrine Gland Neoplasms Ovarian Diseases Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013