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Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
This study is currently recruiting participants.
Study NCT00647153   Information provided by National Cancer Institute (NCI)
First Received: March 28, 2008   Last Updated: June 23, 2009   History of Changes

March 28, 2008
June 23, 2009
May 2006
June 2011   (final data collection date for primary outcome measure)
Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00647153 on ClinicalTrials.gov Archive Site
  • Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66 [ Designated as safety issue: No ]
  • Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66 [ Designated as safety issue: No ]
  • Safety of iodine I 123 anti-CEA recombinant diabody T84.66 [ Designated as safety issue: Yes ]
Same as current
 
Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Pre-Surgical Detection of Colorectal Carcinomas Using 123Iodine-Labeled cT84.66 Diabody Antibody Fragments to Carcinoembryonic Antigen (CEA)

RATIONALE: Diagnostic procedures, such as immunoscintigraphy, using a radiolabeled monoclonal antibody may help find and diagnose colorectal cancer.

PURPOSE: This clinical trial is studying how well immunoscintigraphy using a radiolabeled monoclonal antibody works in finding tumor cells in patients with colorectal cancer.

OBJECTIVES:

Primary

  • To determine the ability of iodine I 123 anti-CEA recombinant diabody T84.66 to localize to colorectal cancer, as determined by quantitative radioimmunoscintigraphy in patients with colorectal cancer.

Secondary

  • To evaluate the clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66 clearance in these patients.
  • To characterize the frequency and titer of the human anti-chimeric response to iodine I 123 anti-CEA recombinant diabody T84.66 in these patients.
  • To determine the safety of iodine I 123 anti-CEA recombinant diabody T84.66 in these patients.

OUTLINE: Patients receive an infusion of iodine I 123 anti-CEA recombinant diabody T84.66. Patients undergo planar imaging every 5 minutes during the radiolabeled antibody infusion and then at 3-6 hrs, 12-24 hours, and, if indicated, 30-48 hours after the radiolabeled antibody infusion. Planar spot images of the head, chest, abdomen, and pelvis and whole body images (anterior and posterior) are taken. Patients also undergo SPECT scan of the abdomen and pelvis at 12 and 24 hours after the radiolabeled antibody infusion.

Blood samples are collected for pharmacokinetic analysis immediately after the radiolabeled antibody infusion and then at 15 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours after the radiolabeled antibody infusion.

Patients are followed periodically for 6 months.

 
Interventional
Diagnostic, Open Label
Colorectal Cancer
  • Other: pharmacological study
  • Procedure: single photon emission computed tomography
  • Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
10
 
June 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal cancer

    • Stage I-IV disease

PATIENT CHARACTERISTICS:

  • Serum creatinine < 2.0 mg/dL
  • Total bilirubin < 2.0 mg/dL
  • Hemoglobin > 9.0 g/dL
  • cT84.66 antibody negative (if previously treated with mouse or chimeric immunoglobulins)
  • Not pregnant
  • No condition that, in the opinion of the investigator, would preclude study compliance
  • No known allergy to iodine
  • No known history of HIV, hepatitis B, or hepatitis C

PRIOR CONCURRENT THERAPY:

  • No concurrent steroids
Both
18 Years and older
No
 
United States
 
NCT00647153
 
CDR0000590136, CHNMC-04085
Beckman Research Institute
National Cancer Institute (NCI)
Principal Investigator: Jeffrey Y. Wong, MD Beckman Research Institute
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP