Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer
I. Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2
(deleted CH2 region) in patients with colorectal cancer.
II. Determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and
conjugate stability of this drug in these patients.
III. Determine the ability of this drug to localize to tumor sites in these patients.
IV. Determine the immune response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1
and a therapy dose over 30 minutes on day 8.
Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody
CC49-deltaCH2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as
the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5
patients experience reversible grade 4 hematologic toxicity.
Patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of 131I-HuCC49^CH2 based on dose-limiting toxicities
University of Alabama at Birmingham
United States: Food and Drug Administration
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|