A Pilot Study of Radioimmunodetection of 124-Iodine-labeled Humanized A33 Antibody (124I-huA33) in Patients With Colorectal Cancer
This is an open-label, pilot study of a single 4mCi-10mCi/10mg IV dose of 124I-huA33 in
patients with colorectal cancer. Patients will be studied with 124I-huA33 positron-emission
tomography (PET), and in the subset of patients scheduled for surgery, based on clinical
indications, ex vivo quantitation of tumor uptake will also be performed. Patients will
receive a single intravenous or intraarterial infusion of 4 mCi-10mCi /10mg 124I-huA33 in
5-30ml of 5% human serum albumin (HSA), over 5-10 minutes. Patient will either receive the
124I-huA33 intravenously (IV) or intraarterially (IA) to determine if there is an advantage
of the IV vs the IA route. Following injection with 124I-huA33, on study days 2, 3, and/ or
4, patients will have the option to receive up to 2g/1kg of Immune Globulin (IVIG).
Blood samples will be obtained for pharmacokinetic analysis at 5, 15, 60, and 120 minutes
after completion of IV or IA infusion, on day 2, 3, and/ or 4, and before and after the PET
scan on the day of surgery or last imaging day (day 8 + 3). Patients scheduled for surgery
will undergo a PET scan of the abdomen and pelvis 1-6 hours prior to surgery.
In those patients undergoing surgery, surgery (or biopsy) will be scheduled to occur day 8
(± 3 days) days after administration of 124I-huA33. Biopsy sites may include tumor, tumor
bed, regional nodes, portal, suprapancreatic, celiac nodes and the retroperitoneum. Tumor
and normal tissue obtained at surgery (or biopsy), and serum will be measured for estimation
of percent-injected dose per gram of tumor, normal liver, and serum. Tissue samples will be
obtained for autoradiography and immunohistochemistry as an additional assessment of tumor
Blood samples to determine immunogenicity will be taken at baseline and at 4 weeks.
Toxicity assessments will be made throughout the study period.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To determine and quantify tumor uptake of radiolabeled antibody from measurements with:
Until end of study
Steven M Larson, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|