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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00647153
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE March 28, 2008
First Posted Date  ICMJE March 31, 2008
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE May 2006
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66 [ Time Frame: Day 2 post infusion ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
  • Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66 [ Time Frame: Day 2 post infusion ]
  • Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66 [ Time Frame: 6 months post infusion ]
  • Safety of iodine I 123 anti-CEA recombinant diabody T84.66 [ Time Frame: 6 months post infusion ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
  • Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66
  • Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66
  • Safety of iodine I 123 anti-CEA recombinant diabody T84.66
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
Interventions:
  • Other: pharmacological study
  • Procedure: single photon emission computed tomography
  • Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2012)
1
Original Enrollment  ICMJE
 (submitted: March 28, 2008)
10
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00647153
Other Study ID Numbers  ICMJE 04085
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-04085
CDR0000590136 ( Registry Identifier: NCI PDQ )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jeffrey Y. Wong, MD City of Hope Comprehensive Cancer Center
PRS Account City of Hope Medical Center
Verification Date November 2017

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