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

Sponsor:	City of Hope Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	City of Hope Medical Center
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:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
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: Iodine Iodide

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:

Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66 [ Time Frame: Day 2 post infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66 [ Time Frame: Day 2 post infusion ] [ Designated as safety issue: No ]
Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66 [ Time Frame: 6 months post infusion ] [ Designated as safety issue: No ]
Safety of iodine I 123 anti-CEA recombinant diabody T84.66 [ Time Frame: 6 months post infusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	May 2006
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion.

One day post infusion

10mCi/mg

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
Duarte, California, United States, 91010-3000

Sponsors and Collaborators

City of Hope Medical Center

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

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00647153 History of Changes
Other Study ID Numbers:	04085, P30CA033572, CHNMC-04085, CDR0000590136
Study First Received:	March 28, 2008
Last Updated:	February 15, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:

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:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

Rectal Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2012