Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies: a Clinical Phase I Trial
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Dyspnea according to CTCAE v4.0
研究概览
简要总结
This clinical study aims to explore intrapleural low-dose Visudyne®-mediated photodynamic therapy (photo-induction) as a pathway to promote the uptake of systemically administered Lipoplatin™ in pleural malignancies of patients undergoing video-assisted talcage for their malignant pleural effusions. Photo-induction is expected to overcome the chemo-resistance of pleural malignancies for cisplatin-based chemotherapeutics and thereby improve local tumor control.
详细描述
The primary objective of the study is to assess the safety and tolerability of intrapleural Visudyne®-mediated photo-induction as a means to selectively increase tumor uptake of systemically administered Lipoplatin™ in patients with primary or secondary pleural malignancies.
The secondary objectives are:
Assessment of treatment efficacy as measured by dyspnea reduction, pleural effusion free survival as well as local relapse rate, progression free and median overall survival.
Analysis of the pleural intratumor penetration of Lipoplatin™ by repeated biopsies for Lipoplatin concentration measurements before and after Visudyne® treatment as well as vessel modulation related parameters (pericyte coverage, vessels morphology).
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 80 Years（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
研究组 & 干预措施
Lipoplatin/Visudyne-mediated photodynamic therapy
200 mg/m2 Lipoplatin™ will be delivered as iv perfusion. Then, intrapleural photo-induction will be realized through a classical video-assisted thoracoscopic (VATS) approach using 3 mg/m2 Visudyne® activated at 689 nm. At the end of the procedure, the patients will receive chemical pleurodesis by VATS as per standard-of-care treatment for malignant pleural effusion.
干预措施: Cisplatin, liposomal (Drug)
Lipoplatin/Visudyne-mediated photodynamic therapy
200 mg/m2 Lipoplatin™ will be delivered as iv perfusion. Then, intrapleural photo-induction will be realized through a classical video-assisted thoracoscopic (VATS) approach using 3 mg/m2 Visudyne® activated at 689 nm. At the end of the procedure, the patients will receive chemical pleurodesis by VATS as per standard-of-care treatment for malignant pleural effusion.
干预措施: Verteporfin (Drug)
Lipoplatin/Visudyne-mediated photodynamic therapy
200 mg/m2 Lipoplatin™ will be delivered as iv perfusion. Then, intrapleural photo-induction will be realized through a classical video-assisted thoracoscopic (VATS) approach using 3 mg/m2 Visudyne® activated at 689 nm. At the end of the procedure, the patients will receive chemical pleurodesis by VATS as per standard-of-care treatment for malignant pleural effusion.
干预措施: Device for Intrapleural Visudyne-mediated Low-Dose Photodynamic Therapy with integrated in situ light dosimetry (Device)
结局指标
主要结局
Dyspnea according to CTCAE v4.0
时间窗: 30-day postoperative
Tolerability of the treatment as assessed by 30-day postoperative mortality
时间窗: 30 days
survival status at 30 days
Safety of the treatment as assessed by 30-day postoperative mortality
时间窗: 30 days
survival status at 30 days
Feasibility
时间窗: 30 days
survival status at 30 days
Acute respiratory failure rate
时间窗: 30-day postoperative
Chest pain rate according to CTCAE v4.0
时间窗: 30-day postoperative
Dyspnea according to Medical Research Council (MRC) chronic dyspnea scale (5-point)
时间窗: 30-day postoperative
次要结局
- Dyspnea reduction according to CTCAE v4.0(30 days after treatment)
- Progression-free survival (PFS)(according to local standard)
- Duration of Response (DOR)(according to local standard)
- Malignant effusion recurrence-free - percentage of patients without recurrent pleural effusion at 30 days(30 days after treatment)
- Overall survival (OS)(every 3 months up to 3 years)
- Tumor response(according to local standard)
- Overall response rate (ORR) based on investigator assessment according to Response(according to local standard)
研究者
Solange Peters
Associate physician
Centre Hospitalier Universitaire Vaudois