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

November 2, 2017 updated by: City of Hope Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
Other: pharmacological study
Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion.
Procedure: single photon emission computed tomography
One day post infusion
Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
10mCi/mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame: Day 2 post infusion
Day 2 post infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame: Day 2 post infusion
Day 2 post infusion
Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame: 6 months post infusion
6 months post infusion
Safety of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame: 6 months post infusion
6 months post infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jeffrey Y. Wong, MD, City of Hope Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04085
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-04085
  • CDR0000590136 (Registry Identifier: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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