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Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting
RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease. PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer.
OBJECTIVES: * Assess the pharmacokinetics and tissue distribution of anti-CEA x anti-HSG bispecific monoclonal antibody TF2 in patients with colorectal cancer. OUTLINE: This is a multicenter study. Patients receive iodine I 131-labeled anti-CEA x anti-HSG bispecific monoclonal antibody TF2 (\^131I-TF2) IV over 10-20 minutes on day 1. Patients also undergo whole-body external scintigraphy at various times during the study. Blood samples are collected at baseline and periodically after \^131I-TF2 infusion for pharmacokinetic studies and \^131I-TF2 biodistribution by ELISA and radioactivity measurements.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Start Date
November 1, 2008
Primary Completion Date
March 1, 2010
Last Updated
September 17, 2013
9
ESTIMATED participants
enzyme-linked immunosorbent assay
OTHER
pharmacological study
OTHER
whole-body scintigraphy
PROCEDURE
iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2
RADIATION
Lead Sponsor
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
NCT06696768
NCT04704661
Data Source & Attribution
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