Study Using WST11 in Patients With Obstructing Endobronchial Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00974662|
Recruitment Status : Terminated (Early end of enrolment with regards to difficulty met to enrol patients.)
First Posted : September 10, 2009
Last Update Posted : April 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: WST11||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||December 2011|
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
- The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter. [ Time Frame: Week 1, Month 1 ]
- 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 ]
- Quality of life will be assessed through the validated patient questionnaires [ Time Frame: Baseline, Week 1, Month 1 & Month 3 ]
- To assess pharmacokinetic parameters of WST11 [ Time Frame: Day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974662
|Principal Investigator:||Michel Leroy, MD||Hopital Foch|