Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

Phase 1

• Conditions: Colorectal Cancer

• Registration Number: NCT00895323
• Lead Sponsor: Garden State Cancer Center at the Center for Molecular Medicine and Immunology

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Status Verified: 2009-07
• Primary Completion: 2010-03
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics
Tissue distribution

Trial Locations

Locations (1)

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States