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

Sponsor
Centre Hospitalier Universitaire Vaudois
Study ID
NCT02702700
Phase
PHASE1
Status
Terminated

Conditions

  • Pleural Effusion, Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin, liposomal — DRUG
    Lipoplatin IV 200 mg/m2
  • Verteporfin — DRUG
    Visudyne® IV 3 mg/m2
  • Device for Intrapleural Visudyne-mediated Low-Dose Photodynamic Therapy with integrated in situ light dosimetry — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2016
Status verified
Mar 2019
Primary completion
Aug 28, 2018
Completion
Aug 28, 2018

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Safety of the treatment as assessed by 30-day postoperative mortality [ Time Frame: 30 days ]

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