Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies
- Conditions
- Pleural Effusion, Malignant
- Interventions
- Drug: Cisplatin, liposomalDevice: Device for Intrapleural Visudyne-mediated Low-Dose Photodynamic Therapy with integrated in situ light dosimetry
- Registration Number
- NCT02702700
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lipoplatin/Visudyne-mediated photodynamic therapy Device for Intrapleural Visudyne-mediated Low-Dose Photodynamic Therapy with integrated in situ light dosimetry 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. Lipoplatin/Visudyne-mediated photodynamic therapy Cisplatin, liposomal 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. Lipoplatin/Visudyne-mediated photodynamic therapy Verteporfin 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.
- Primary Outcome Measures
Name Time Method Dyspnea according to CTCAE v4.0 30-day postoperative Tolerability of the treatment as assessed by 30-day postoperative mortality 30 days survival status at 30 days
Safety of the treatment as assessed by 30-day postoperative mortality 30 days survival status at 30 days
Feasibility 30 days survival status at 30 days
Acute respiratory failure rate 30-day postoperative Chest pain rate according to CTCAE v4.0 30-day postoperative Dyspnea according to Medical Research Council (MRC) chronic dyspnea scale (5-point) 30-day postoperative
- Secondary Outcome Measures
Name Time Method Dyspnea reduction according to CTCAE v4.0 30 days after treatment CTCAE v4.0
Progression-free survival (PFS) according to local standard Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Duration of Response (DOR) according to local standard Evaluation Criteria in Solid Tumors (RECIST) version 1.1
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 Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Overall response rate (ORR) based on investigator assessment according to Response according to local standard Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Trial Locations
- Locations (1)
Oncology Department, Centre Hospitalier Universitaire Vaudois (CHUV)
🇨🇭Lausanne, Vaud (VD), Switzerland