Spots Global Cancer Trial Database for Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
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Trial Identification
Brief Title: Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
Official Title: A Single-Arm, Open-Label, Phase II Study to Assess the Safety and Efficacy of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intraperitoneally in Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Study ID: NCT00326885
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.
Detailed Description: A multi-center, phase II study of catumaxomab in ovarian cancer patients with recurrent symptomatic malignant ascites requiring therapeutic paracentesis. Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 3-4 days. Each patient will participate in this study for up to 7 months (includes the baseline therapeutic paracentesis and screening period, 11 to 21 days treatment period, and up to 180 days/6 months follow-up), with monthly post-study follow-up for the lifetime of the patient. Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells (DCs) and natural killer (NK) cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, Tucson, Arizona, United States
University of San Diego, La Jolla, California, United States
Stanford University Hospital and Clinics, Stanford, California, United States
University of Miami, Miami, Florida, United States
Florida Hospital Cancer Center, Orlando, Florida, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
University of Louisville Cancer Center, Louisville, Kentucky, United States
Johns Hopkins Medical Institute, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Wayne State University, Detroit, Michigan, United States
Dartmouth-Hitchock Medical Center, Lebanon, New Hampshire, United States
Columbia University Cancer center, New York, New York, United States
Wake-Forest University, Winston-Salem, North Carolina, United States
University of Oklahoma Health Science Center, Oklahoma City, Oklahoma, United States
Magee Women's Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania, United States
The Methodist Hospital, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Contact Details
Name: Jonathan Berek, MD MMSc
Affiliation: Stanford University Hospital and Clinics, Department of Obstetrics and Gynecology
Role: STUDY_CHAIR
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