Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer|
|Study Start Date:||December 2002|
|Study Completion Date:||March 2004|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058435
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Paul Sabbatini, MD||Memorial Sloan Kettering Cancer Center.|