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

NCT00974662 | Terminated Phase 2

• 1 other identifier: CLIN903 LCM201
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

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

  Week 1, Month 1

Secondary Outcomes (3)

• 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

Study Arms (1)

WST11

EXPERIMENTAL

Treatment with WST11-mediated VTP

Drug: WST11

Interventions

WST11 DRUG

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).

Also known as: WST11-mediated VTP

WST11

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steba Biotech S.A.: lead

Study Sites (1)

Hopital Foch

Suresnes, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

padeliporfin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michel Leroy, MD

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2011
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

FR (1)