Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pre-Surgical Detection of Colorectal Carcinomas Using 123Iodine-Labeled cT84.66 Diabody Antibody Fragments to Carcinoembryonic Antigen (CEA)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: pharmacological study
* Procedure: single photon emission computed tomography
* Radiation: iodine I 123 anti-CEA recombinant diabody T84.66


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention 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<br> | Other: pharmacological study<br>* Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion.<br>Procedure: single photon emission computed tomography<br>* One day post infusion<br>Radiation: iodine I 123 anti-CEA recombinant diabody T84.66<br>* 10mCi/mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66 |  | Day 2 post infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66 |  | Day 2 post infusion | 
| Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66 |  | 6 months post infusion | 
| Safety of iodine I 123 anti-CEA recombinant diabody T84.66 |  | 6 months post infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer