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Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00058435
Study type Interventional
Source Memorial Sloan Kettering Cancer Center
Contact
Status Completed
Phase Phase 1
Start date December 2002
Completion date March 2004

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