NCT00103545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_1 ovarian-cancer

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2005

Completed
Last Updated

October 2, 2006

Status Verified

February 1, 2006

First QC Date

February 10, 2005

Last Update Submit

September 29, 2006

Conditions

Ovarian CancerFallopian Tube NeoplasmsPeritoneal Neoplasms

Keywords

Ovarian CancerACA 1256 or 9 vaccinationsimmune responseFallopian tube cancerPeritoneal cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

ACA 125BIOLOGICAL

Eligibility Criteria

Age0 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Clinic for Gynecology and Gyn. Oncology, Humboldt University

Berlin, 10117, Germany

Location

University Clinic Carl Gustav Carus, Gynecological hospital

Dresden, 01307, Germany

Location

Gynecologic Hospital

Düsseldorf, 40217, Germany

Location

University Gynecologic Hospital

Essen, 45122, Germany

Location

University Gynecologic Hospital

Frankfurt, 60596, Germany

Location

Gynecologic Clinic of the Ernst-Moritz-Arndt-University

Greifswald, 17487, Germany

Location

University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics

Kiel, 24105, Germany

Location

Otto-von-Guericke University, University Gynecological Hospital

Magdeburg, 39108, Germany

Location

Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology

Marburg, 35033, Germany

Location

University Gynecological Hospital

Ulm, 89075, Germany

Location

Clinic for Gnyecology and gyn. Oncology HSK

Wiesbaden, 65199, Germany

Location

Related Publications (1)

  • 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.

    PMID: 17005631BACKGROUND

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal Neoplasms

Interventions

abagovomab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesAbdominal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Study Officials

  • Jacobus Pfisterer, Prof. Dr.

    AGO Study Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2005

First Posted

February 11, 2005

Study Start

July 1, 2003

Study Completion

August 1, 2004

Last Updated

October 2, 2006

Record last verified: 2006-02

Locations

DE(11)