A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Confirmation of Tumor Targeting as Measured by the Number of Patients With Assessable Lesions Greater Than or Equal to 2 cm Measured by FDG-PET and SPECT Imaging.
研究概览
简要总结
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).
详细描述
OBJECTIVES:
Primary
- Determine the targeting, tissue distribution, and pharmacokinetics of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).
Secondary
- Determine the immunogenicity of of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).
- Determine tumor response of monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).
- Determine the safety of tof monoclonal antibody hu3S193 in patients with progressive small cell lung cancer (SCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Confirmation of Tumor Targeting as Measured by the Number of Patients With Assessable Lesions Greater Than or Equal to 2 cm Measured by FDG-PET and SPECT Imaging.
时间窗: 28 days
Gamma camera imaging, including planar scans and single-photon emission computed tomography (SPECT) scans, were carried out immediately following completion of infusion and on two subsequent occasions during the next 6 days after the infusions of 111In-hu3S193 on weeks 1 and 4. A pretreatment FDG-positron emission tomography PET/CT scan was performed within 2 weeks of study entry per standard clinical methods for comparison with gamma camera imaging. FDG-PET/ CT scans and 111In planar and SPECT scans were evaluated for extent of disease and antibody targeting, respectively. Lesions on FDG-PET/CT scans were considered positive if uptake of radiotracer was visually greater than surrounding tissue, with a standard uptake value greater than 3.
次要结局
- Number of Patients With Tumor Responses After Treatment With hu3S193 as Measured by RECIST(up to 28 days)
- Mean Clearance (CL) as Measured by 111In-hu3S193 Radioactivity(4 weeks (days 1, 2, 3, and 5; weeks 1 and 4))
- Mean Half-life (T1/2) as Measured by 111In-hu3S193 Radioactivity(4 weeks (days 1, 2, 3, and 5; weeks 1 and 4))
- Mean Volume of Distribution of Central Compartment (V1) as Measured by 111In-hu3S193 Radioactivity(4 weeks (days 1, 2, 3, and 5; weeks 1 and 4))
- Mean Area Under the Curve (AUC) as Measured by 111In-hu3S193 Radioactivity(4 weeks (days 1, 2, 3, and 5; weeks 1 and 4))
- Immunogenicity of hu3S193 as Measured by the Number of Patients With Human Anti-human Antibodies (HAHA) After Treatment With hu3S193.(4 weeks (pre-dose, weeks 1, 2, 3, and 4))