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Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma

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 Cholangiocarcinoma focused on measuring Inoperable, Inoperable Cholangiocarcinoma, Non-resectable, Non-resectable Cholangiocarcinoma, Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Patient having signed the consent form to take part in the study
  • Patient aged over 18 years, with no upper age limit
  • Patient with histologically proven cholangiocarcinoma
  • Patient with cholangiocarcinoma, inoperable or non resectable owing to extension, age or concomitant diseases
  • Bilirubin level decrease of more than 50% after stent insertion compared to base level
  • Patient with a WHO Performance Scale ≤ 2
  • Patient in whom efficient drainage is performed by means of a plastic biliary stent endoscopically or radiologically
  • Patient capable of completing the quality of life questionnaires
  • Women of child-bearing potential must have a negative pregnancy test, and must thereafter prove to be using acceptable contraception (oral contraceptive pill, hormone patches, or IUD)

Exclusion Criteria:

  • Absence of consent to take part in the study
  • Patient with operable biliary carcinoma
  • Class ASA IV patients
  • Patients presenting clinical and laboratory signs of biliary infection
  • Absence of bilirubin decrease after stent insertion
  • Patients with extrinsic biliary compression
  • Patients already having received or currently receiving radiotherapy or chemotherapy for cholangiocarcinoma or needing to be treated during the first month of the follow-up
  • Known metastatic lesions
  • Patients having received immediate treatment by insertion of a metal stent
  • Patients with porphyria or known hypersensitivity to porphyrins (contraindication to WST11)
  • Patient receiving prohibited treatment at the time of inclusion in the study
  • Pregnant or breast-feeding women
  • Non-menopausal women not using effective contraception
  • Majors under protection as per the French Public Health Code
  • Persons not registered with or covered by a social security system
  • Persons in an exclusion period relative to other biomedical study

Sites / Locations

  • Clinique de l'Alma

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WST11

Arm Description

Treatment with WST11-mediated VTP

Outcomes

Primary Outcome Measures

Evaluation of the safety based on analysis of adverse events , clinical laboratory tests, electrocardiogram, physical examination, absence of local or general complications and phototoxicity of WST11 in inoperable or non resectable cholangiocarcinoma

Secondary Outcome Measures

Evaluation of the antitumor efficacy of WST11-mediated VTP therapy by comparing the objective response rate on the tumor.
Evaluation of the effect of WST11-mediated VTP therapy on cholestasis and on the incidence of biliary complications of obstructive origin.
Evaluation of the effect of treatment on patient quality of life QLQ-C30.
Evaluation of the global survival after WST11-mediated VTP

Full Information

First Posted
September 10, 2009
Last Updated
April 14, 2016
Sponsor
Steba Biotech S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00975039
Brief Title
Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma
Official Title
Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
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
June 2011 (Actual)
Study Completion Date
September 2012 (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 evaluate the safety of Vascular Targeted Photodynamic therapy with WST11 in patients with non-resectable or inoperable biliary carcinoma.
Detailed Description
This is an open-label, prospective, multicentre, phase IIa study, evaluating a new therapeutic agent in the management of patients suffering from inoperable or non resectable biliary carcinoma. The patients will receive the dose of WST11 according to order of inclusion. The first 3 patients will receive 2.5 mg/kg. In the absence of toxicity, the following 9 patients will receive the dose of 5 mg/kg. The patient is to receive anesthesia. WST11-mediated therapy will consist of the combination of single IV administration of WST11 at doses of 2.5mg/kg or 5mg/kg, using 753nm laser light at a fixed power of (150mW/cm) and light energy (200 J/cm) delivered through a diffusing fiber. The fiber is introduced in a transparent standard ERCP catheter and positioned under radioscopy in front of the lesion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
Inoperable, Inoperable Cholangiocarcinoma, Non-resectable, Non-resectable Cholangiocarcinoma, Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (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 consist of the combination of a single IV administration of WST11 at doses of 2.5 and 5 mg/kg, using 753nm laser light at a fixed power (150 mW/cm) and light energy (200 J/cm). Illumination in the bile duct is performed by inserting a diffusing fiber, with cylindrical uniform light distribution, in a transparent standard ERCP catheter and by positioning, under radioscopy, the illumination tip of the diffusing fiber in front of the lesion.
Primary Outcome Measure Information:
Title
Evaluation of the safety based on analysis of adverse events , clinical laboratory tests, electrocardiogram, physical examination, absence of local or general complications and phototoxicity of WST11 in inoperable or non resectable cholangiocarcinoma
Time Frame
Patient inclusion - Month 6
Secondary Outcome Measure Information:
Title
Evaluation of the antitumor efficacy of WST11-mediated VTP therapy by comparing the objective response rate on the tumor.
Time Frame
Month 1, Month 3 & Month 6
Title
Evaluation of the effect of WST11-mediated VTP therapy on cholestasis and on the incidence of biliary complications of obstructive origin.
Time Frame
Month 1, Month 3 & Month 6
Title
Evaluation of the effect of treatment on patient quality of life QLQ-C30.
Time Frame
Month 1, Month 3 & Month 6
Title
Evaluation of the global survival after WST11-mediated VTP
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient having signed the consent form to take part in the study Patient aged over 18 years, with no upper age limit Patient with histologically proven cholangiocarcinoma Patient with cholangiocarcinoma, inoperable or non resectable owing to extension, age or concomitant diseases Bilirubin level decrease of more than 50% after stent insertion compared to base level Patient with a WHO Performance Scale ≤ 2 Patient in whom efficient drainage is performed by means of a plastic biliary stent endoscopically or radiologically Patient capable of completing the quality of life questionnaires Women of child-bearing potential must have a negative pregnancy test, and must thereafter prove to be using acceptable contraception (oral contraceptive pill, hormone patches, or IUD) Exclusion Criteria: Absence of consent to take part in the study Patient with operable biliary carcinoma Class ASA IV patients Patients presenting clinical and laboratory signs of biliary infection Absence of bilirubin decrease after stent insertion Patients with extrinsic biliary compression Patients already having received or currently receiving radiotherapy or chemotherapy for cholangiocarcinoma or needing to be treated during the first month of the follow-up Known metastatic lesions Patients having received immediate treatment by insertion of a metal stent Patients with porphyria or known hypersensitivity to porphyrins (contraindication to WST11) Patient receiving prohibited treatment at the time of inclusion in the study Pregnant or breast-feeding women Non-menopausal women not using effective contraception Majors under protection as per the French Public Health Code Persons not registered with or covered by a social security system Persons in an exclusion period relative to other biomedical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Ben Soussan, MD
Organizational Affiliation
Clinique de l'Alma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de l'Alma
City
Paris
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Using WST11 in Patients With Non-Resectable or Inoperable Cholangiocarcinoma

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