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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647153
• Other study ID #: 04085
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: Phase 1
• First received: March 28, 2008
• Last updated: November 2, 2017
• Start date: May 2006
• Est. completion date: October 2012

Study information

• Verified date: November 2017
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66		Day 2 post infusion
Secondary	Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66		Day 2 post infusion
Secondary	Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66		6 months post infusion
Secondary	Safety of iodine I 123 anti-CEA recombinant diabody T84.66		6 months post infusion