Status:
COMPLETED
Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC)
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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 * Dete...
Eligibility Criteria
Inclusion
- Small cell lung cancer, pathologically confirmed. Measurable disease, including at least one lesion measuring ≥ 2 cm that has not been previously irradiated.
- Progression of disease after one, two, or three prior chemotherapy regimens. At least 4 weeks since the last chemotherapy or radiation treatment. Karnofsky performance status ≥ 70% (ECOG 0 or 1).
- The following laboratory results within the last 2 weeks prior to study day 1:
- White Blood Cell Count (WBC) ≥ 3,500/mm3; Platelet count ≥ 100 x 10\^9/L; Serum creatinine ≤ 2.0 mg/dL; Serum bilirubin ≤ 2.0 mg/dL; International normalized ratio (INR) ≤ 1.3; Women of childbearing potential with confirmed negative quantitative serum HCG on the day of administration of study agent.
- Negative stool guaiac test (read by laboratory). Tumor tissue positive for Lewis Y expression.
Exclusion
- Clinically significant cardiac disease (New York Heart Association Class III/IV).
- Uncontrolled brain or leptomeningeal metastases. GI bleed within the preceding 6 months. Patients with history of receiving mouse monoclonal antibody. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Women who are pregnant or breast-feeding.
Key Trial Info
Start Date :
July 26 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00084799
Start Date
July 26 2004
End Date
December 20 2006
Last Update
October 4 2023
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021