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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-04085 | |||
| CDR0000590136 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation: iodine I 123 anti-CEA recombinant diabody T84.66 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacological study | Other | Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66 | Day 2 post infusion |
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Y. Wong, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
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| single photon emission computed tomography | Procedure | One day post infusion |
|
| iodine I 123 anti-CEA recombinant diabody T84.66 | Radiation | 10mCi/mg |
|
| Safety of iodine I 123 anti-CEA recombinant diabody T84.66 | 6 months post infusion |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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