Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

City of Hope

Status and phase: Completed; Phase 1

Conditions: Colorectal Cancer

Treatments: Procedure: single photon emission computed tomography; Radiation: iodine I 123 anti-CEA recombinant diabody T84.66; Other: pharmacological study

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00647153

04085

CHNMC-04085

P30CA033572 (U.S. NIH Grant/Contract)

CDR0000590136 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Radiation: iodine I 123 anti-CEA recombinant diabody T84.66

Experimental group

Treatment:

Procedure: single photon emission computed tomography

Radiation: iodine I 123 anti-CEA recombinant diabody T84.66

Other: pharmacological study