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.
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
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1
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
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66
Time frame: Day 2 post infusion
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
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