Study Using WST11 in Patients With Obstructing Endobronchial Non-Small Cell Lung Cancer
The aim of this study is to determine the dose of WST11 and light energy necessary to obtain desobstruction of the bronchial lumen using Vascular Targeted Photodynamic therapy in obstructive Non-Small Cell Lung Cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer|
- The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter. [ Time Frame: Week 1, Month 1 ] [ Designated as safety issue: No ]
- The evaluation of safety will be based on adverse events reporting throughout the duration of the study, on the monitoring of vital signs and ECGs, on laboratory tests,clinical examination and chest X Ray. [ Time Frame: Screening-Month 3 ] [ Designated as safety issue: Yes ]
- Quality of life will be assessed through the validated patient questionnaires [ Time Frame: Baseline, Week 1, Month 1 & Month 3 ] [ Designated as safety issue: No ]
- To assess pharmacokinetic parameters of WST11 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Treatment with WST11-mediated VTP
WST11-mediated VTP will consists of the combination of a single IV administration of WST11 at doses of 5, 7.5 & 10 mg/kg, using 753 nm laser light at a fixed power of 250 mW/cm and escalating fixed energy dose (200 Joules/cm and 300 Joules/cm) locally delivered to the obstructing tumor through an optical fiber placed, during endoscopy, in the endoscope operating channel with visual control, possibly video-transmission assisted. The fiber illuminating diffusion length is fixed (2 cm).
Other Name: WST11-mediated VTP
This study is designed as a multicentre, exploratory phase IIa, open label, single intravenous (IV) dose, escalating treatment regimen (Treatment regimen = a single dose of WST11 associated with a particular laser light energy) with a one month follow-up.
Six escalating treatment regimens will be followed: 3 WST11 doses (5 mg/kg; 7.5 mg/kg and 10 mg/kg) combined with 2 light energies (200 Joules/cm and 300 Joules/cm)
The patient will be treated under local anesthesia. The light is produced using a specific laser at a wavelength of 753 nm at a fixed power of 250 mW/cm and locally delivered to the obstructing tumor through an optical fiber placed, during endoscopy, in the endoscope operating channel with visual control, possibly video-transmission assisted. The fiber illuminating diffusion length is fixed (2 cm).