Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00084799|
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : June 16, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: monoclonal antibody Hu3S193||Phase 1|
- Determine the targeting, tissue distribution, and pharmacokinetics of monoclonal antibody Hu3S193 in patients with progressive small cell lung cancer.
- Determine the immunogenicity of this drug in these patients.
- Determine tumor response in patients treated with this drug.
- Determine the safety of this drug in these patients.
OUTLINE: This is an open-label, pilot study.
Patients receive monoclonal antibody Hu3S193 (MOAB Hu3S193) IV over 30 minutes on day 1 of weeks 1-4. Patients also receive indium In III MOAB Hu3S193 IV over 30 minutes on day 1 of weeks 1 and 4 and then undergo gamma camera imaging. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 and 4 weeks, every 3 months for 1 year, and then every 6-12 months thereafter.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer|
|Study Start Date :||February 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084799
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Lee M. Krug, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Chaitanya R. Divgi, MD||Memorial Sloan Kettering Cancer Center|