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

NCT00975039 | Terminated Phase 2

• 1 other identifier: CLIN904 CCM201
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Keywords

Inoperable; Inoperable Cholangiocarcinoma; Non-resectable; Non-resectable Cholangiocarcinoma; Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

  Patient inclusion - Month 6

Secondary Outcomes (4)

• Evaluation of the antitumor efficacy of WST11-mediated VTP therapy by comparing the objective response rate on the tumor.

  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.

  Month 1, Month 3 & Month 6

• Evaluation of the effect of treatment on patient quality of life QLQ-C30.

  Month 1, Month 3 & Month 6

• Evaluation of the global survival after WST11-mediated VTP

  Month 6

Study Arms (1)

WST11

EXPERIMENTAL

Treatment with WST11-mediated VTP

Drug: WST11

Interventions

WST11 DRUG

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.

Also known as: WST11-mediated VTP

WST11

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Steba Biotech S.A.: lead

Study Sites (1)

Clinique de l'Alma

Paris, France

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Carcinoma

Interventions

padeliporfin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Emmanuel Ben Soussan, MD

  Clinique de l'Alma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2012
• Last Updated: April 18, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)