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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00084799
Study type Interventional
Source Ludwig Institute for Cancer Research
Contact
Status Completed
Phase Phase 1
Start date July 26, 2004
Completion date December 20, 2006

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