Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 11/8/2017 |
| Start Date: | May 2006 |
| End Date: | October 2012 |
Pre-Surgical Detection of Colorectal Carcinomas Using 123Iodine-Labeled cT84.66 Diabody Antibody Fragments to Carcinoembryonic Antigen (CEA)
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.
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.
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.
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
We found this trial at
1
site
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
Click here to add this to my saved trials
