Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer - Full Text View

Sponsor:	Beckman Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00647153

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.

Condition	Intervention
Colorectal Cancer	Other: pharmacological study Procedure: single photon emission computed tomography Radiation: iodine I 123 anti-CEA recombinant diabody T84.66

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Pre-Surgical Detection of Colorectal Carcinomas Using 123Iodine-Labeled cT84.66 Diabody Antibody Fragments to Carcinoembryonic Antigen (CEA)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Cadexomer iodine Iodine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	10
Study Start Date:	May 2006
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647153

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Preeyarat Kloythanomsup 800-826-4673

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jeffrey Y. Wong, MD

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000590136, CHNMC-04085
Study First Received:	March 28, 2008
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00647153 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Anti-Infective Agents
Digestive System Neoplasms
Gastrointestinal Diseases
Growth Substances
Physiological Effects of Drugs
Colonic Diseases
Trace Elements
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions

Intestinal Neoplasms
Anti-Infective Agents, Local
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Iodine
Micronutrients
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009