CompletedPhase 1NCT00084799

Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer (SCLC)

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).

Checked against the public recordLast updated Oct 4, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations1
SponsorLudwig Institute for Cancer Research
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Ludwig Institute for Cancer Research
Interventions being studied
Biological: monoclonal antibody hu3S193
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 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 Criteria: 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Sloan-Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 4, 2023. Always confirm current availability with the study team.

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