Skip to main content
OpenTrials
Completed

NCT Number: NCT00647153

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pharmacological study

Other

Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion.

Single Photon Emission Computed Tomography

Procedure

One day post infusion

iodine I 123 anti-CEA recombinant diabody T84.66

Radiation

10mCi/mg

Primary outcomes

  1. Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66

    Time frame: Day 2 post infusion

Secondary outcomes

  1. Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66

    Time frame: Day 2 post infusion

  2. Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66

    Time frame: 6 months post infusion

  3. Safety of iodine I 123 anti-CEA recombinant diabody T84.66

    Time frame: 6 months post infusion

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Mar 31, 2008
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.