Primary Outcome Measures:
- Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66 [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66 [ Designated as safety issue: No ]
- Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66 [ Designated as safety issue: No ]
- Safety of iodine I 123 anti-CEA recombinant diabody T84.66 [ Designated as safety issue: Yes ]
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.
Purpose
