Non-Small Cell Lung CancerPhase 2NCT00974662
Study Using WST11 in Patients With Obstructing Endobronchial Non-Small Cell Lung Cancer
A Phase 2 study testing WST11 in people with Non-Small Cell Lung Cancer, run by Steba Biotech S.A. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- WST11
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer
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.
Read the 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).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- WST11
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WST11Drug
Also called WST11-mediated VTP
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).
| Study group | Role | What they receive |
|---|---|---|
| WST11 | Experimental | Treatment with WST11-mediated VTP Receives: Drug: WST11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter.
Measured: 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.
Measured: Screening-Month 3
Quality of life will be assessed through the validated patient questionnaires
Measured: Baseline, Week 1, Month 1 & Month 3
To assess pharmacokinetic parameters of WST11
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2010
- Study completionDec 2011
Why it stopped: Early end of enrolment with regards to difficulty met to enrol patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steba Biotech S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Leroy, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974662
- Sponsor's protocol ID
- CLIN903 LCM201
- Status last verified
- Apr 2015
- First submitted
- 9 Sep 2009
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00974662
- Acronym / sponsor ID
- CLIN903 LCM201
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Lung Cancer, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early end of enrolment with regards to difficulty met to enrol patients.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Steba Biotech S.A.University, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WST11 | Experimental | Drug: WST11Treatment with WST11-mediated VTP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WST11Also: WST11-mediated VTPWST11-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). | Drug | WST11 |
Primary outcome
The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter.
Time frame: Week 1, Month 1
3 secondary outcomes
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
Quality of life will be assessed through the validated patient questionnaires
Time frame: Baseline, Week 1, Month 1 & Month 3
To assess pharmacokinetic parameters of WST11
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Early end of enrolment with regards to difficulty met to enrol patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Leroy, MD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WST11 in people with Non-Small Cell Lung Cancer, run by Steba Biotech S.A. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Early end of enrolment with regards to difficulty met to enrol patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter. (time frame: Week 1, Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.