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Study Using WST11 in Patients With Obstructing Endobronchial Non-Small Cell Lung Cancer

Primary Purpose

Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
WST11
Sponsored by
Steba Biotech S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, Lung Cancer, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WST11

Arm Description

Treatment with WST11-mediated VTP

Outcomes

Primary Outcome Measures

The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter.

Secondary Outcome Measures

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.
Quality of life will be assessed through the validated patient questionnaires
To assess pharmacokinetic parameters of WST11

Full Information

First Posted
September 9, 2009
Last Updated
April 27, 2015
Sponsor
Steba Biotech S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00974662
Brief Title
Study Using WST11 in Patients With Obstructing Endobronchial Non-Small Cell Lung Cancer
Official Title
Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Early end of enrolment with regards to difficulty met to enrol patients.
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steba Biotech S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Non-Small Cell Lung Cancer, Lung Cancer, NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WST11
Arm Type
Experimental
Arm Description
Treatment with WST11-mediated VTP
Intervention Type
Drug
Intervention Name(s)
WST11
Other Intervention Name(s)
WST11-mediated VTP
Intervention Description
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).
Primary Outcome Measure Information:
Title
The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter.
Time Frame
Week 1, Month 1
Secondary Outcome Measure Information:
Title
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
Title
Quality of life will be assessed through the validated patient questionnaires
Time Frame
Baseline, Week 1, Month 1 & Month 3
Title
To assess pharmacokinetic parameters of WST11
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Leroy, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
Country
France

12. IPD Sharing Statement

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Study Using WST11 in Patients With Obstructing Endobronchial Non-Small Cell Lung Cancer

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