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

This study has been terminated.
(Early end of enrolment with regards to difficulty met to enrol patients despite previous protocol amendments.)
Sponsor:
Information provided by (Responsible Party):
Steba Biotech S.A.
ClinicalTrials.gov Identifier:
NCT00974662
First received: September 9, 2009
Last updated: July 4, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: WST11
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Steba Biotech S.A.:

Primary Outcome Measures:
  • The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter. [ Time Frame: Week 1, Month 1 ] [ Designated as safety issue: No ]

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. [ Time Frame: Screening-Month 3 ] [ Designated as safety issue: Yes ]
  • Quality of life will be assessed through the validated patient questionnaires [ Time Frame: Baseline, Week 1, Month 1 & Month 3 ] [ Designated as safety issue: No ]
  • To assess pharmacokinetic parameters of WST11 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WST11
Treatment with WST11-mediated VTP
Drug: WST11
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974662

Locations
France
Hopital Foch
Suresnes, France
Sponsors and Collaborators
Steba Biotech S.A.
Investigators
Principal Investigator: Michel Leroy, MD Hopital Foch
  More Information

No publications provided

Responsible Party: Steba Biotech S.A.
ClinicalTrials.gov Identifier: NCT00974662     History of Changes
Other Study ID Numbers: CLIN903 LCM201
Study First Received: September 9, 2009
Last Updated: July 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Steba Biotech S.A.:
Non-Small Cell Lung Cancer
Lung Cancer
NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014