Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

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.

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

Detailed Description:


  • 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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Pharmacokinetics
  2. Tissue distribution

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed colorectal cancer

    • Radiological documentation of disease is preferred, but not required


  • Karnofsky performance status 70-100%
  • Life expectancy ≥ 3 months
  • WBC ≥ 3,000/mm³
  • Neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum creatinine normal
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST/ALT < 2 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 1 month after completion of study therapy
  • No medical conditions that might prevent full participation in protocol-required testing or follow-up
  • No institutionalized patients (e.g., in prisons or mental health institutions)


  • No concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its 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      
Sponsors and Collaborators
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Principal Investigator: Aiwu R. He, MD Lombardi Comprehensive Cancer Center

Responsible Party: Sylvia Gargiulo, Garden State Cancer Center and Center for Molecular Medicine and Immunology Identifier: NCT00895323     History of Changes
Other Study ID Numbers: CDR0000636332
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs