NCT00006046

Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Ludwig Institute for Cancer Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	monoclonal antibody hu3S193

Timeline

• Start date: 2000-07-12
• Primary completion: 2001-10-05
• Completion: 2002-09-24
• First posted: 2003-05-21
• Last updated: 2023-10-04
• Results posted: 2021-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study