Phase I Dose-Escalation /Phase II Monocentric Open Trial for Evaluation of Safety and Efficacy of Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication or Extrapleural Pneumonectomy for the Treatment of Patients With Malignant Pleural Mesothelioma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety)
研究概览
简要总结
The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication or extrapleural pneumonectomy in a phase I and II study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model (phase I), and confirmation of safety and efficacy in phase II with the maximum tolerated dose in phase I.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety)
时间窗: during 6 weeks after surgery with local cisplatin-fibrin application
(Serious) Adverse Events \& safety blood parameters (hematology and clinical chemistry)
Cisplatin concentration in the superficial chest wall tissue
时间窗: 90 min after application
local cisplatin concentration in the superficial chest wall biopsy measured by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection
次要结局
- overall survival(up to 5 years (phase I), up to 2 years (phase II))
- FFR (= Freedom From Recurrence)(4, 16 weeks, then every 4 months up to 5 (phase I) / 2 years (phase II))
- in-treatment-field FFR (= Freedom From Recurrence)(up to 2 years (phase II))
- Quality of Life SF-36 (= Short Form-36)(phase I: 0, 4, 8, 16 weeks and every 4w up to 5y; phase II: 0, 6, 16w and every 4w up to 2y)
- Quality of Life EORTC QLQ-C15/LC13 (QLQ = Quality of Life Questionnaire, C = Cancer, LC = Lung Cancer)(phase I: 0, 4, 8, 16 weeks and every 4w up to 5y; phase II: 0, 6, 16w and every 4w up to 2y)
- pharmacokinetics cisplatin concentration in blood serum(baseline, and 0, 2, 6, 10, 24, 48, 120 h postoperative)
- pharmacokinetics cisplatin concentration in urine(baseline, collection of first 48h, day 14 postoperative)
- TUNEL assay(before and 90 min after cisplatin-fibrin application)
- PAI-1 and p21 (PAI-1 = Plasminogen Activator Inhibitor Typ 1, p21 = CDK-Inhibitor 1 = Cyclin Dependent Kinase Inhibitor 1))(before and 90 min after cisplatin-fibrin application)