Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|