Study Using WST11 in Patients With Obstructing Endobronch... | NCT00974662

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

NCT00974662

Sponsor

Steba Biotech S.A.

Status

Terminated

Last Update Posted

Apr 28, 2015Estimated

Enrollment

3Actual

Phase

Phase 2

Conditions

Non-Small Cell Lung Cancer

Interventions

WST11

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Early end of enrolment with regards to difficulty met to enrol patients.

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Dec 2011Actual

First Submitted Date

Sep 9, 2009

First Submission Date that Met QC Criteria

Sep 9, 2009

First Posted Date

Sep 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2015

Last Update Posted Date

Apr 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WST11	Experimental	Treatment with WST11-mediated VTP	Drug: WST11

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter.		Week 1, Month 1

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms