A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer
A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer
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).
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, pilot study.
Patients received monoclonal antibody hu3S193 (mAb hu3S193) intravenously (IV) over 30 minutes on day 1 of weeks 1-4. Patients also received indium-111 (111In) radiolabeled hu3S193 IV over 30 minutes on day 1 of weeks 1 and 4 and then underwent gamma camera imaging. Treatment continued in the absence of disease progression or unacceptable toxicity.
Patients were followed at 1 and 4 weeks, every 3 months for 1 year, and then every 6-12 months thereafter.
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.