Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pharmacological study
single photon emission computed tomography
iodine I 123 anti-CEA recombinant diabody T84.66
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer
Eligibility Criteria
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
Sites / Locations
- City of Hope Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
Arm Description
Outcomes
Primary Outcome Measures
Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00647153
First Posted
March 28, 2008
Last Updated
November 2, 2017
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00647153
Brief Title
Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Official Title
Pre-Surgical Detection of Colorectal Carcinomas Using 123Iodine-Labeled cT84.66 Diabody Antibody Fragments to Carcinoembryonic Antigen (CEA)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Description
Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion.
Intervention Type
Procedure
Intervention Name(s)
single photon emission computed tomography
Intervention Description
One day post infusion
Intervention Type
Radiation
Intervention Name(s)
iodine I 123 anti-CEA recombinant diabody T84.66
Intervention Description
10mCi/mg
Primary Outcome Measure Information:
Title
Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame
Day 2 post infusion
Secondary Outcome Measure Information:
Title
Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame
Day 2 post infusion
Title
Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame
6 months post infusion
Title
Safety of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame
6 months post infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Y. Wong, MD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
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