Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
The goal of the study is to identify the maximum tolerated dose of endobronchial ultrasound-guided transbronchial injection (EBUS-TBNI) of cisplatin for Stage IV lung cancer.
详细描述
Multiple studies have demonstrated feasibility and safety of delivering cisplatin directly into lung tumors using endobronchial ultrasound guided-transbronchial needle injection (EBUS-TBNI). This technique relies on the use of a bronchoscope with an integrated ultrasound transducer allowing real-time visualization of, and delivery of cisplatin into, tumors lying in proximity to the central airways. Prior work has utilized this technique to treat loco regional recurrence in a previously radiated field. The goal of the current study is to identify the initial dose for intratumoral cisplatin. Phase 1A is a dose ranging study. Phase 1B is designed to evaluate the safety of delivery of the drug into different tumor regions .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 years or above
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- •Have known or suspected metastatic NSCLC at time of enrollment (including patients who progress on initial therapy or are found to have metastatic disease during therapy and are not excluded based on 8.2 below).
- •Ability and willingness to provide informed consent
- •A CT scan of the chest (with or without contrast) within the prior 3 months.
- •The presence of an EBUS accessible target site. These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS
- •Patients must have adequate organ and marrow function as defined below:
- •Leukocytes ≥3,000/mcL
- •Platelets ≥100,000/mcL
- •Total bilirubin ≤ institutional upper limit of normal (ULN)
- •AST(SGOT)/ALT(SGPT) ≤ institutional ULN
- •Glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2 via CKD EPI)
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
排除标准
- •Use of an investigational agent in prior 30 days
- •Pregnancy/lactation
- •Treatment with cytotoxic chemotherapy within the past 30 days
- •Prior (within the last 12 months) or ongoing radiation treatment to the study NSCLC
- •Allergy to cisplatin or its derivatives
- •Patient not appropriate for the research study based on physician discretion
研究组 & 干预措施
Initial Treatment- Low Perfusion Region
Phase 1B uses a within group comparison. All participants will undergo 1 delivery of intratumoral cisplatin into either a low or high perfusion region, then the subsequent week undergo delivery into the other region, for a total of 3 treatments.
干预措施: cisplatin (Drug)
结局指标
主要结局
Dose limiting toxicity
时间窗: 14 days
次要结局
未报告次要终点
研究者
C. Matthew Kinsey MD, MPH
Director, Interventional Pulmonary
University of Vermont