Pleural Effusion, Malignant Clinical Trial
Official title:
Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies: a Clinical Phase I Trial
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).
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