Phase I Study of Targeted Lung Chemotherapy in the Treatment of Metastatic Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Acute toxicity assessed using CTCAE version 4.0
研究概览
简要总结
This phase I trial studies the side effects and best dose of cisplatin in treating patients with stage IIIB-IV non-small cell lung cancer or tumors that have spread from where they started to the lung (metastasis). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cisplatin directly into the arteries around the tumor may kill more tumor cells and cause less damage to normal tissue.
详细描述
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose and dose-limiting toxicities of cisplatin when delivered selectively by isolated lung suffusion to patients with any biopsy or cytologically proven resectable or unresectable primary or secondary malignancy in the lung.
SECONDARY OBJECTIVES:
I. To assess lung tissue levels of cisplatin after isolated lung suffusion as a function of the dose delivered.
II. To evaluate systemic and pulmonary artery concentrations of cisplatin during isolated lung suffusion.
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
- •Any biopsy or cytologically proven resectable or unresectable primary or secondary (metastatic) malignancy in the lung; this is defined as
- •Tumors whose only remaining residual deposits are confined to the lungs OR
- •Oligometastatic tumors with > 80% of measurable tumor volume in the target lung In both of the above situations, no clinical evidence of central nervous system (CNS) metastases can exist; oligometastatic disease is difficult to define but would, as a guideline, have only 1-4 loci of disease established in 1-2 organ systems outside the affected lung; exceptions to these guidelines can occur, particularly in cases where sites of metastatic disease are equivocal or so minute that it would not exceed 20% of tumor volume
- •Unresectable stage IV non-small cell lung cancer (NSCLC)
- •Unresectable stage IIIB NSCLC
- •Resectable metastatic sarcoma to lung (thoracoscopically resectable)
- •Other malignancies that meet the criteria
- •Eastern Cooperative Oncology Group performance status 0-1
- •No oxygen needs (oxygen use per standard established criteria for oxygen requirements)
- •Modified Borg dyspnea scale < 5
- •Six minute walk >= 50% of the expected distance; this will not be used as exclusion criteria if due to a reason other than respiratory per judgment of physician e.g., pain
- •Ambulatory and resting oxygen (O2) saturation > 88%
- •PPO (predicted post operative)* forced expiratory volume in one second (FEV1) >= 50% predicted
- •PPO values should be calculated for each patient
- •PPO * diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% predicted
- •PPO values should be calculated for each patient
- •PPO * vital capacity >= 50% predicted
- •PPO values should be calculated for each patient
- •Granulocytes > 1,500 ul
- •Platelets >= 100,000 ul
- •Patients must sign a study-specific consent form prior to registration
- •Tumor anatomy must allow the isolated lung suffusion in the judgment of the principal investigator (PI)
排除标准
- •Uncontrolled intercurrent disease
- •Prior chemotherapy for proven metastatic disease within 4 weeks
- •Evidence of pulmonary toxicity from previous or ongoing chemotherapy
- •Creatinine > 1.5 mg/dL
- •Liver enzymes > 2 times upper normal
- •Uncontrolled congestive heart failure (in judgment of the PI)
- •Optional: ejection fraction < 40% for clinical evidence of insufficient cardiac reserve (multi gated acquisition scan [MUGA] or echocardiogram [ECHO] will be done only if indicated in the judgment of the PI)
- •Myocardial infarction or angina within past 6 months
- •Contraindications to anticoagulation
- •Hydration intolerance (e.g., uncontrolled congestive heart failure [CHF])
- •Human immunodeficiency virus positive (HIV+) on antiretroviral therapy
- •Pregnant or lactating
- •Diffuse pulmonary fibrosis involving over 25% of the total lung parenchyma
- •Previous radiation for thorax
- •Metastatic sarcoma to lung that is not able to have tumors resected thoracoscopically
- •Prior lung removal in the affected lung (would have decreased lung volume)
研究组 & 干预措施
Treatment (cisplatin)
Patients receive cisplatin intra-arterially via isolated lung suffusion over 2 hours. Beginning approximately 2 weeks later (6-8 weeks if indicated for patients with sarcoma undergoing surgery after cisplatin), patients receive standard chemotherapy regimen.
干预措施: Cisplatin (Drug)
Treatment (cisplatin)
Patients receive cisplatin intra-arterially via isolated lung suffusion over 2 hours. Beginning approximately 2 weeks later (6-8 weeks if indicated for patients with sarcoma undergoing surgery after cisplatin), patients receive standard chemotherapy regimen.
干预措施: Pharmacological Study (Other)
结局指标
主要结局
Acute toxicity assessed using CTCAE version 4.0
时间窗: Within 7 days from lung infusion
Frequency of patients experiencing dose limiting toxicities (DLT) as well as non-DLT
时间窗: Within 30 days of the procedure
DLT is defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A grade 3 or above adverse event shall be considered a DLT in this study if attributed to the isolated lung suffusion cisplatin dose.
Reversibility of all toxicities from this approach.
时间窗: Up to 90 days from the start of lung infusion therapy
次要结局
- Lung, systemic, and pulmonary artery concentrations of cisplatin(Before pulmonary artery release, at 15 minutes, and 1 hour)
- Pulmonary function test with diffusion capacity(Up to 30 days post-treatment)
- Split lung function test(Up to 30 days post-treatment)