Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Recruitment status was: Recruiting
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.
Other: enzyme-linked immunosorbent assay
Other: pharmacological study
Procedure: whole-body scintigraphy
Radiation: iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting|
- Pharmacokinetics [ Designated as safety issue: No ]
- Tissue distribution [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895323
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Aiwu R. He, MD||Lombardi Comprehensive Cancer Center|