Clinical trial NCT00103545: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Keywords: Ovarian Cancer
ACA 125
6 or 9 vaccinations
immune response
Fallopian tube cancer
Peritoneal cancer
Lead sponsor: AGO Study Group
Sponsor class: OTHER
First posted: 2005-02-11
Enrollment: 36
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Safety, feasibility and tolerability
measure: The primary endpoint is drop-out due to toxicity as the overall measure of feasibility
Secondary outcomes:
measure: Duration and strength of the immune response induced by ACA 125 vaccination
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Clinic for Gynecology and Gyn. Oncology, Humboldt University
city: Dresden
country: Germany
facility: University Clinic Carl Gustav Carus, Gynecological hospital
city: Duesseldorf
country: Germany
facility: Gynecologic Hospital
city: Essen
country: Germany
facility: University Gynecologic Hospital
city: Frankfurt
country: Germany
facility: University Gynecologic Hospital
city: Greifswald
country: Germany
facility: Gynecologic Clinic of the Ernst-Moritz-Arndt-University
city: Kiel
country: Germany
facility: University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics
city: Magdeburg
country: Germany
facility: Otto-von-Guericke University, University Gynecological Hospital
city: Marburg
country: Germany
facility: Clinic of the Philipps University Marburg, Clinic for gynecology, gyn. endocrinology and oncology
city: Ulm
country: Germany
facility: University Gynecological Hospital
city: Wiesbaden
country: Germany
facility: Clinic for Gnyecology and gyn. Oncology HSK
Study officials:
affiliation: AGO Study Group
name: Jacobus Pfisterer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.