- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00647153
Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Pre-Surgical Detection of Colorectal Carcinomas Using 123Iodine-Labeled cT84.66 Diabody Antibody Fragments to Carcinoembryonic Antigen (CEA)
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.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
|
Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion.
Day 1 and 2 post infusion.
One day post infusion
10mCi/mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame: Day 2 post infusion
|
Day 2 post infusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame: Day 2 post infusion
|
Day 2 post infusion
|
Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame: 6 months post infusion
|
6 months post infusion
|
Safety of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame: 6 months post infusion
|
6 months post infusion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeffrey Y. Wong, MD, City of Hope Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04085
- P30CA033572 (U.S. NIH Grant/Contract)
- CHNMC-04085
- CDR0000590136 (Registry Identifier: NCI PDQ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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