Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00895323|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 8, 2009
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||March 2010|
- Tissue distribution
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895323
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center 202-444-0381|
|Principal Investigator:||Aiwu R. He, MD||Lombardi Comprehensive Cancer Center|