Expired Study
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Duarte, California 91010


Purpose:

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 summary:

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.


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


NCT ID:

NCT00647153


Primary Contact:

Principal Investigator
Jeffrey Y. Wong, MD
City of Hope Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Duarte, California 91010
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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