Ovarian CancerPhase 1/2NCT00103545
Use of ACA 125 in Patients With Ovarian Cancer: Safety and Immune Response
A Phase 1/2 study testing ACA 125 in people with Ovarian Cancer and Fallopian Tube Neoplasms, run by AGO Study Group at 11 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 0 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Neoplasms, Peritoneal Neoplasms
- What is being tested?
- ACA 125
- How many people
- 36 participants
- Where
- 11 sitesGermany
- Study dates
- Jul 2003to Aug 2004
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Clinic for Gynecology and Gyn. Oncology, Humboldt University
Berlin, 10117
University Clinic Carl Gustav Carus, Gynecological hospital
Dresden, 01307
Gynecologic Hospital
Düsseldorf, 40217
University Gynecologic Hospital
Essen, 45122
University Gynecologic Hospital
Frankfurt, 60596
Gynecologic Clinic of the Ernst-Moritz-Arndt-University
Greifswald, 17487
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
Kiel, 24105
Otto-von-Guericke University, University Gynecological Hospital
Magdeburg, 39108
Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology
Marburg, 35033
University Gynecological Hospital
Ulm, 89075
Clinic for Gnyecology and gyn. Oncology HSK
Wiesbaden, 65199
About this study
Official title: A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
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.
Read the 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.
- Being tested
- ACA 125
- Keywords
- Ovarian Cancer, ACA 125, 6 or 9 vaccinations, immune response, Fallopian tube cancer, Peritoneal cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACA 125Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, feasibility and tolerability
The primary endpoint is drop-out due to toxicity as the overall measure of feasibility
Secondary outcomes (1)
Duration and strength of the immune response induced by ACA 125 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2005 (estimated)
- Study startJul 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- AGO Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Jacobus Pfisterer, Prof. Dr., Principal investigator, AGO Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103545
- Sponsor's protocol ID
- AGO-OVAR 2.8
- Status last verified
- Feb 2006
- First submitted
- 10 Feb 2005
- Last updated
- 2 Oct 2006
- Results posted
- No
Publications
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.
PubMed 17005631
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT00103545
- Acronym / sponsor ID
- AGO-OVAR 2.8
- Keywords
- Ovarian Cancer, ACA 125, 6 or 9 vaccinations, immune response, Fallopian tube cancer, Peritoneal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- AGO Study GroupUniversity, hospital or other
- Study start
- Jul 2003
- Study completion
- Aug 2004
- First posted
- 11 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACA 125 | Biological | – |
Primary outcome
Safety, feasibility and tolerability
The primary endpoint is drop-out due to toxicity as the overall measure of feasibility
1 secondary outcome
Duration and strength of the immune response induced by ACA 125 vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2006.
- Background: PubMed 17005631Pfisterer 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.
- Information on studies of the AGO-OVAR on Ovarian cancerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacobus Pfisterer, Prof. Dr. principal investigator
AGO Study Group
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACA 125 in people with Ovarian Cancer and Fallopian Tube Neoplasms, run by AGO Study Group at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, feasibility and tolerability. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00103545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2006.