Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced colorectal cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma|
|Study Start Date:||January 2000|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006046
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Sydney Welt, MD||Memorial Sloan Kettering Cancer Center.|