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Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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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

- Patients with risk of large vessel erosion or perforation resulting from lesion

- 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:


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:


Principal Investigator

Michel Leroy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hopital Foch


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CLIN903 LCM201



Start Date:

September 2009

Completion Date:

December 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms