Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

March 28, 2008

Last Updated Date

June 23, 2009

Start Date ^ICMJE

May 2006

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66 [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00647153 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

Official Title ^ICMJE

Pre-Surgical Detection of Colorectal Carcinomas Using 123Iodine-Labeled cT84.66 Diabody Antibody Fragments to Carcinoembryonic Antigen (CEA)

Brief Summary

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.

Detailed Description

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

Other: pharmacological study
Procedure: single photon emission computed tomography
Radiation: iodine I 123 anti-CEA recombinant diabody T84.66

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00647153

Responsible Party

Study ID Numbers ^ICMJE

CDR0000590136, CHNMC-04085

Study Sponsor ^ICMJE

Beckman Research Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Jeffrey Y. Wong, MD

Beckman Research Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2009

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