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A Randomized, Double-Blind, Placebo-Controlled, Phase IIB Study of the Safety and Efficacy of OVAREX MabB43.13 in Ovarian Cancer Patients With an Elevated Serum CA 125 But Without Other Evidence of Disease
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have ovarian, fallopian tube, or peritoneal cancer.
OBJECTIVES: I. Determine the safety of OvaRex monoclonal antibody B43.13 in patients with elevated CA 125 and histologically proven epithelial adenocarcinoma of the ovary, fallopian tube, or peritoneum, but without other evidence of disease. II. Determine the time to disease progression, overall survival, CA 125 levels, immune responses, and quality of life of these patients treated with this regimen. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive placebo IV during weeks 1, 3, 5, 9, 13, 25, 37, and 49. Arm II: Patients receive OvaRex monoclonal antibody B43.13 (MOAB B43.13) IV during weeks 1, 3, 5, 9, 13, 25, 37, and 49. Patients in either treatment arm who have no disease progression after week 49 receive MOAB B43.13 once every 12 weeks until week 121. Patients with disease progression after week 49 may receive MOAB B43.13 alone, in combination with, or following chemotherapy. Quality of life is assessed during the study. PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Gynecologic Oncology Associates
Newport Beach, California, United States
Lee Memorial Health System
Fort Myers, Florida, United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Mercy Medical Center, Inc.
Baltimore, Maryland, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Start Date
November 1, 1998
Last Updated
November 6, 2013
102
ESTIMATED participants
oregovomab
BIOLOGICAL
Lead Sponsor
AltaRex
NCT04550494
NCT05039801
Data Source & Attribution
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