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

April 14, 2016 updated by: Steba Biotech S.A.

Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Clinique de l'Alma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WST11
Treatment with WST11-mediated VTP
Drug: WST11
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.
Other Names:
  • WST11-mediated VTP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Patient inclusion - Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Month 1, Month 3 & Month 6
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
Month 1, Month 3 & Month 6
Evaluation of the effect of treatment on patient quality of life QLQ-C30.
Time Frame: Month 1, Month 3 & Month 6
Month 1, Month 3 & Month 6
Evaluation of the global survival after WST11-mediated VTP
Time Frame: Month 6
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steba Biotech S.A.

Investigators

  • Principal Investigator: Emmanuel Ben Soussan, MD, Clinique de l'Alma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN904 CCM201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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