Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
NCT ID: NCT00647153
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
1 participants
INTERVENTIONAL
2006-05-31
2012-10-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
pharmacological study
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
One day post infusion
iodine I 123 anti-CEA recombinant diabody T84.66
10mCi/mg
Interventions
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pharmacological study
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
One day post infusion
iodine I 123 anti-CEA recombinant diabody T84.66
10mCi/mg
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Y. Wong, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Countries
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Other Identifiers
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CHNMC-04085
Identifier Type: -
Identifier Source: secondary_id
CDR0000590136
Identifier Type: REGISTRY
Identifier Source: secondary_id
04085
Identifier Type: -
Identifier Source: org_study_id