NCT00084799

Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC)

A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (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: This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with progressive small cell lung cancer (SCLC).

Detailed description

OBJECTIVES: Primary * Determine the targeting, tissue distribution, and pharmacokinetics of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC). Secondary * Determine the immunogenicity of of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC). * Determine tumor response of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC). * Determine the safety of tof monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC). OUTLINE: This is an open-label, pilot study. Patients received monoclonal antibody hu3S193 (mAb hu3S193) intravenously (IV) over 30 minutes on day 1 of weeks 1-4. Patients also received indium-111 (111In) radiolabeled hu3S193 IV over 30 minutes on day 1 of weeks 1 and 4 and then underwent gamma camera imaging. Treatment continued in the absence of disease progression or unacceptable toxicity. Patients were followed at 1 and 4 weeks, every 3 months for 1 year, and then every 6-12 months thereafter.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	monoclonal antibody hu3S193

Timeline

• Start date: 2004-07-26
• Primary completion: 2006-01-25
• Completion: 2006-12-20
• First posted: 2004-06-11
• Last updated: 2023-10-04
• Results posted: 2022-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study