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


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66

Outcome Time Frame:

Day 2 post infusion

Safety Issue:

No

Principal Investigator

Jeffrey Y. Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

04085

NCT ID:

NCT00647153

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • 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
  • Colorectal Neoplasms

Name

Location
City of Hope Comprehensive Cancer Center Duarte, California  91010