Clinical Trial: Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies: a Clinical Phase I Trial

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 Summary:

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).


Sponsor: Centre Hospitalier Universitaire Vaudois

Current Primary Outcome:

  • Safety of the treatment as assessed by 30-day postoperative mortality [ Time Frame: 30 days ]
    survival status at 30 days
  • Tolerability of the treatment as assessed by 30-day postoperative mortality [ Time Frame: 30 days ]
    survival status at 30 days
  • Feasibility [ Time Frame: 30 days ]
    survival status at 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 30 days after treatment ]
    CTCAE v4.0
  • Tumor response [ Time Frame: according to local standard ]
    Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Overall survival (OS) [ Time Frame: every 3 months up to 3 years ]
  • Overall response rate (ORR) based on investigator assessment according to Response [ Time Frame: according to local standard ]
    Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Progression-free survival (PFS) [ Time Frame: according to local standard ]
    Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Duration of Response (DOR) [ Time Frame: according to local standard ]
    Evaluation Criteria in Solid Tumors (RECIST) version 1.1


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire Vaudois

Dates:
Date Received: January 25, 2016
Date Started: January 2016
Date Completion: June 2019
Last Updated: March 3, 2016
Last Verified: February 2016