Colorectal Cancer Clinical Trial
Official title:
Phase I Study of 131I-Labeled Humanized Antibody A33 in Patients With Advanced Colorectal Carcinoma
RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing
substances, such as radioactive iodine, to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in
treating patients with advanced colorectal cancer.
OBJECTIVES: I. Define the toxicity and determine the maximum tolerated dose of iodine I 131
humanized monoclonal antibody A33 (131I-huAb A33) in patients with advanced colorectal
cancer. II. Describe pharmacokinetics and biodistribution of 131I-huAb A33 by external
imaging in these patients. III. Determine the effect of human antihuman antibody response on
pharmacokinetics and targeting of 131I-huAb A33 in this patient population. IV. Determine
whether the dose planning methodology used here can adequately and safely be applied to
routine radioimmunotherapy planning.
OUTLINE: Patients receive iodine I 131 humanized monoclonal antibody A33 (131I-huAb A33) by
IV infusion over 20 minutes every 6-8 days for up to 8 weeks (depending on dosage). Patients
receive a minimum of 6 weeks of treatments. In the absence of disease progression or
unacceptable toxicity, patients are retreated no sooner than 6 weeks after the previous
course. Cohorts of 3-6 patients receive escalating doses of 131I-huAb A33 to determine the
maximum tolerated dose (MTD). The MTD is defined as the highest dose at which no more than 2
of 6 patients experience dose limiting toxicity. Patients are followed for 6 weeks after the
last treatment.
PROJECTED ACCRUAL: There will be 3-24 patients accrued into this study over 16 months.
;
Primary Purpose: Treatment
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