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

This study has been terminated.

(Early end of enrolment with regards to difficulty met to enrol patients despite previous protocol amendments.)

Sponsor:

Information provided by (Responsible Party):

Steba Biotech S.A.

ClinicalTrials.gov Identifier:

NCT00975039

First received: September 10, 2009

Last updated: July 4, 2012

Last verified: July 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Cholangiocarcinoma	Drug: WST11	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy in Non-resectable or Inoperable Cholangiocarcinoma

Further study details as provided by Steba Biotech S.A.:

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 [ Time Frame: Patient inclusion - Month 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Evaluation of the effect of treatment on patient quality of life QLQ-C30. [ Time Frame: Month 1, Month 3 & Month 6 ] [ Designated as safety issue: No ]
Evaluation of the global survival after WST11-mediated VTP [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]

Enrollment:	7
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2012
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: WST11-mediated VTP

Arms

Assigned Interventions

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 Name: WST11-mediated VTP

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975039

Locations

France
Clinique de l'Alma
Paris, France

Sponsors and Collaborators

Steba Biotech S.A.

Investigators

Principal Investigator:

Emmanuel Ben Soussan, MD

Clinique de l'Alma

More Information

No publications provided

Responsible Party:	Steba Biotech S.A.
ClinicalTrials.gov Identifier:	NCT00975039 History of Changes
Other Study ID Numbers:	CLIN904 CCM201
Study First Received:	September 10, 2009
Last Updated:	July 4, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Steba Biotech S.A.:

Inoperable
Inoperable Cholangiocarcinoma
Non-resectable
Non-resectable Cholangiocarcinoma
Carcinoma

Additional relevant MeSH terms:

Cholangiocarcinoma
Adenocarcinoma
Carcinoma

Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013

To Top