CClinicalTrials.gg
Sign In
CompletedNCT00103545Updated Oct 2, 2006

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

A Phase 1/2 interventional study of ACA 125 in Ovarian Cancer, Fallopian Tube Neoplasms and Peritoneal Neoplasms, sponsored by AGO Study Group. Completed at 11 sites in Germany. Open to female participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2006-10-02.

Sponsored by AGO Study Group · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
0 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Ovarian Cancer
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms

Keywords

  • Ovarian Cancer
  • ACA 125
  • 6 or 9 vaccinations
  • immune response
  • Fallopian tube cancer
  • Peritoneal cancer
03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 36 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

AGO Study Group is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants

Interventions

  • BiologicalACA 125
06

What researchers measure

Primary outcomes

  1. Safety, feasibility and tolerability

  2. 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

07

Study locations

11 sites
  • Clinic for Gynecology and Gyn. Oncology, Humboldt University
    Berlin, 10117, Germany
  • University Clinic Carl Gustav Carus, Gynecological hospital
    Dresden, 01307, Germany
  • Gynecologic Hospital
    Duesseldorf, 40217, Germany
  • University Gynecologic Hospital
    Essen, 45122, Germany
  • University Gynecologic Hospital
    Frankfurt, 60596, Germany
  • Gynecologic Clinic of the Ernst-Moritz-Arndt-University
    Greifswald, 17487, Germany
  • University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
    Kiel, 24105, Germany
  • Otto-von-Guericke University, University Gynecological Hospital
    Magdeburg, 39108, Germany
  • Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology
    Marburg, 35033, Germany
  • University Gynecological Hospital
    Ulm, 89075, Germany
  • Clinic for Gnyecology and gyn. Oncology HSK
    Wiesbaden, 65199, Germany
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00103545
Lead sponsor
AGO Study Group
First posted
Feb 11, 2005
Start date
Jul 2003
Completion
Aug 2004
Last update
Oct 2, 2006

Study contacts

Jacobus Pfisterer, Prof. Dr.
principal investigator · AGO Study Group
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

AGO Study Group

Start the discussion