Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, Lung Cancer, NSCLC
Brief summary
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.
Detailed description
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).
Interventions
DRUGWST11
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).
Sponsors
Steba Biotech S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter. | Week 1, Month 1 |
Secondary
| Measure | Time frame |
|---|---|
| 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. | Screening-Month 3 |
| Quality of life will be assessed through the validated patient questionnaires | Baseline, Week 1, Month 1 & Month 3 |
| To assess pharmacokinetic parameters of WST11 | Day 1 |
Countries
France
Outcome results
None listed