NCT02135588Unknown1 期
Combination Tissue Plasminogen Activator (Tpa) and Dornase Alfa (Dnase) Administration Through Intrapleural Catheters for the Treatment of Loculated or Non-Draining Malignant Pleural Effusions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Radiographic improvement in area of pleural collection
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of intrapleural dornase alfa and tPA administered to patients with clinical failure of small-bore chest tube with persistent pleural effusions or malignancy-related loculated effusion to improve pleural drainage.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical failure of small-bore chest tube with persistent pleural effusion
- •18 years of age or older
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0-
- •Life expectancy ≥ 6 weeks
- •Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.0 g/dL
- •Serum creatinine ≤2.0 times the upper limit of the normal range, total bilirubin ≤ 2.5 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
- •At least 2 days from administration of chemotherapy
- •At least 7 days from prior major surgery
- •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
- •Patient judged to be 'medically stable' by primary investigator.
排除标准
- •Prior treatment with intrapleural fibrinolytic agents
- •Presence of any intracranial mass
- •Traumatic hemorrhagic pleural effusion
- •Major hemorrhage, coincidental stroke, or major trauma
- •High-risk for systemic bleeding
- •Allergy or intolerance to dornase alfa
- •Active clinically serious infection > CTCAE (version 4.03) Grade
- •Serious non-healing wound, ulcer, or bone fracture.
- •Major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery.
- •Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- •Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
- •Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation in this study)
- •Expected survival less than six weeks
研究组 & 干预措施
Active Treatment
Experimental
Intra-pleural deoxyribonuclease 5mg and intra-pleural Alteplase 10mg, every 12 hours over 72 hours (total of 6 treatments)
干预措施: Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE) (Drug)
结局指标
主要结局
Radiographic improvement in area of pleural collection
时间窗: Day 14
次要结局
未报告次要终点
研究者
研究点 (1)
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