Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00006046|
Recruitment Status : Completed
First Posted : May 21, 2003
Last Update Posted : February 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: monoclonal antibody Hu3S193||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma|
|Study Start Date :||January 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|