Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer
18 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer
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).
Inclusion Criteria:
- Histologically proven lung cancer
- Inoperable
- Non-Small Cell Cancer
- Partial or total bronchial obstruction responsible for functional signs
- T1 to T4, N0-N3, M0-M1
- Patients with functional signs: hemoptysis, infection, cough and, above all, dyspnea
- Contralateral metastases not representing a contraindication insofar as they do not
represent a risk of impairment of respiratory function during treatment
- The Karnofsky index should be greater than or equal to 40
- Patients should agree to and tolerate repeated bronchial endoscopy (a disadvantage of
all endoscopic treatments)
- Male or female patients aged over 18 years, female patients should not be pregnant
(menopause or contraception)
- Patients should have given their written consent to take part in the study
Exclusion Criteria:
- Tracheal lesions and lesions affecting the carina tracheae
- Patients with painful bone metastases (not an absolute criterion since the extent of
dyspnea is the decisive element)
- Patients with brain metastases
- Patients having undergone pneumonectomy
- Patients undergoing chemotherapy or radiotherapy or having undergone chemotherapy
less than 4 weeks before the procedure or radiotherapy less than 4 weeks before the
procedure
- Patients with risk of large vessel erosion or perforation resulting from lesion
topography
- In case of allergy to the photosensitizer
- Leukopenia (WBC<2000), Thrombocytopenia (< 100 000), PT > 1.5 normal, Fibrinogen <
2g/l, a PTT > 1.5 ULN (Upper Limit of Normal)
- Renal insufficiency
- Hepatic insufficiency
- Patients having already received 70 Gy on the lesion
- Existing tracheoesophageal or bronchoesophageal fistula
- Emergency treatment of patients with severe acute respiratory distress caused by an
obstructing endobronchial lesion
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter.
Outcome Time Frame:
Week 1, Month 1
Safety Issue:
No
Principal Investigator
Michel Leroy, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hopital Foch
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
CLIN903 LCM201
NCT ID:
NCT00974662
Start Date:
September 2009
Completion Date:
December 2011
Related Keywords:
- Non-Small Cell Lung Cancer
- Non-Small Cell Lung Cancer
- Lung Cancer
- NSCLC
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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