Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma
- Determine the toxicity, maximum tolerated dose, and pharmacokinetics of monoclonal
antibody Hu3S193 in patients with advanced colorectal carcinoma.
- Determine the immune response in these patients treated with this regimen.
OUTLINE: This is a dose escalation study.
Patients receive monoclonal antibody Hu3S193 (MAB Hu3S193) IV over 30 minutes to 4 hours
weekly for 8 weeks followed by 2 weeks of rest. Patients with stable or responding disease
at week 10 receive maintenance MAB Hu3S193 weekly. Courses repeat every 8 weeks in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of MAB Hu3S193 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6
patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study.
Primary Purpose: Treatment
Sydney Welt, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|