Colorectal Cancer
Conditions
Keywords
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
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. 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.
Interventions
OTHERpharmacological study
Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion.
PROCEDUREsingle photon emission computed tomography
One day post infusion
RADIATIONiodine I 123 anti-CEA recombinant diabody T84.66
10mCi/mg
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66 | Day 2 post infusion |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Safety of iodine I 123 anti-CEA recombinant diabody T84.66 | 6 months post infusion |
Countries
United States
Outcome results
None listed