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Spots Global Cancer Trial Database for Monoclonal Antibody Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer

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Trial Identification

Brief Title: Monoclonal Antibody Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer

Official Title: 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

Study ID: NCT00004064

Interventions

oregovomab

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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, Saint Louis, Missouri, United States

St. John's Mercy Medical Center, Saint Louis, Missouri, United States

University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Palmetto Richland Memorial Hospital, Columbia, South Carolina, United States

Texas Oncology, P.A., Dallas, Texas, United States

Cancer Center, University of Virginia HSC, Charlottesville, Virginia, United States

Riverside Regional Medical Center, Newport News, Virginia, United States

Ottawa Regional Cancer Center - General Division, Ottawa, Ontario, Canada

Contact Details

Name: Michael A. Bookman, MD

Affiliation: Fox Chase Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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