NCT00647153CompletedPhase 1
Pre-Surgical Detection of Colorectal Carcinomas Using 123Iodine-Labeled cT84.66 Diabody Antibody Fragments to Carcinoembryonic Antigen (CEA)
City of Hope Medical Center2 sites in 1 country1 target enrollmentStarted: May 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66
Time Frame: Day 2 post infusion
Secondary Outcomes
- Safety of iodine I 123 anti-CEA recombinant diabody T84.66(6 months post infusion)
- 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)
Investigators
Study Sites (2)
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