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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Lipoplatin IV 200 mg/m2
Visudyne® IV 3 mg/m2
Intrapleural photo-induction will be realized in the chest cavity with low-dose PDT using Visudyne® 3mg/m2 as photosensitizer, activated by 689 nm laser light with a fluence of 10J/cm2 and a fluence rate of \<10mWcm2.
Oncology Department, Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Vaud (VD), Switzerland
Safety of the treatment as assessed by 30-day postoperative mortality
survival status at 30 days
Time frame: 30 days
Tolerability of the treatment as assessed by 30-day postoperative mortality
survival status at 30 days
Time frame: 30 days
Feasibility
survival status at 30 days
Time frame: 30 days
Acute respiratory failure rate
Time frame: 30-day postoperative
Dyspnea according to CTCAE v4.0
Time frame: 30-day postoperative
Chest pain rate according to CTCAE v4.0
Time frame: 30-day postoperative
Dyspnea according to Medical Research Council (MRC) chronic dyspnea scale (5-point)
Time frame: 30-day postoperative
Malignant effusion recurrence-free - percentage of patients without recurrent pleural effusion at 30 days
Time frame: 30 days after treatment
Dyspnea reduction according to CTCAE v4.0
CTCAE v4.0
Time frame: 30 days after treatment
Tumor response
Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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Time frame: according to local standard
Overall survival (OS)
Time frame: every 3 months up to 3 years
Overall response rate (ORR) based on investigator assessment according to Response
Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: according to local standard
Progression-free survival (PFS)
Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: according to local standard
Duration of Response (DOR)
Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: according to local standard