Spots Global Cancer Trial Database for Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

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Trial Identification

Brief Title: Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

Official Title: Phase I Study of Humanized 3S193 (Anti-Lewis-Y) Antibody in Patients With Advanced Colorectal Carcinoma

Study ID: NCT00006046

Conditions

Colorectal Cancer

Interventions

monoclonal antibody hu3S193

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * 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.