Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

OBJECTIVES: Primary - Determine the targeting, tissue distribution, and pharmacokinetics of monoclonal antibody Hu3S193 in patients with progressive small cell lung cancer. Secondary - 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed small cell lung cancer - Progressive disease after 1-3 prior chemotherapy regimens - Measurable disease - At least 1 measurable lesion ≥ 2 cm that is not in a previously irradiated field - Positive immunohistochemical staining for Lewis Y - No uncontrolled brain or leptomeningeal metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% OR - ECOG 0-1 Life expectancy - Not specified Hematopoietic - WBC ≥ 3,500/mm^3 - Platelet count ≥ 150,000/mm^3 Hepatic - Bilirubin ≤ 2.0 mg/dL - INR ≤ 1.3 Renal - Creatinine ≤ 2.0 mg/dL Cardiovascular - No clinically significant cardiac disease - No New York Heart Association class III or IV cardiac disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Stool guaiac test negative - No gastrointestinal bleed within the past 6 months PRIOR CONCURRENT THERAPY: Biologic therapy - No prior mouse monoclonal antibody Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy Surgery - Not specified Other - More than 4 weeks since prior participation in any other clinical trial involving another investigational agent


NCT ID:

NCT00084799


Primary Contact:

Principal Investigator
Lee M. Krug, MD
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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