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

Phase 1

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: pharmacological study; Procedure: single photon emission computed tomography; Radiation: iodine I 123 anti-CEA recombinant diabody T84.66

• Registration Number: NCT00647153
• Lead Sponsor: City of Hope Medical Center

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 Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66	Day 2 post infusion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States