Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

Phase 1

Completed

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00058435
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.

Detailed Description

OBJECTIVES:

* Determine the safety of varying routes and doses of monoclonal antibody ACA125 anti-idiotype vaccine in patients with ovarian epithelial, fallopian tube, or peritoneal cancer.

* Determine an optimal dose and route of this vaccine for a phase II study.

* Determine the immune response induced by this vaccination in these patients.

* Determine the time to development of objective tumor response in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive lower-dose monoclonal antibody ACA125 anti-idiotype vaccine (MOAB ACA125) intramuscularly (IM) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.

* Arm II: Patients receive higher-dose MOAB ACA125 IM as in arm I.

* Arm III: Patients receive lower-dose MOAB ACA125 subcutaneously (SC) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.

* Arm IV: Patients receive higher-dose MOAB ACA125 SC as in arm III. Patients are followed every 6-12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 40 patients (10 patients per cohort) will be accrued for this study.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2003-04-07
• Study First Submitted QC: 2003-04-08
• Study First Posted: 2003-04-09
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States