Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

November 16, 2009 updated by: University of Salzburg

A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

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

  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Department of Internal Medicine I, Paracelsus Medical University Salzburg
        • Contact:
        • Principal Investigator:
          • Frieder Berr, Prof., MD
  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • Internal Medicine Dept., University Medical Center Hamburg-Eppendorf
        • Contact:
        • Principal Investigator:
          • A. Lohse, Prof., MD

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:

    1. Bismuth type III or IV ( not resectable with R0-margins )
    2. Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient
  • sufficient general condition to undergo PDT (Karnofsky status > 30%)
  • age > 19 years
  • access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
  • informed written consent

Exclusion Criteria:

  • porphyria or other diseases exacerbated by light
  • known intolerance or allergies to porphyrin derivatives
  • a planned surgical procedure within the next 30 days
  • coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days
  • impaired kidney or liver function (creatinine > 2.5x elevated, INR > 2.2 on vitamin K),
  • leukopenia ( WBC < 2000/cmm ) or thrombopenia ( < 50000/cmm ),
  • cytotoxic chemotherapy within the past 4 weeks.
  • pregnancy ( and safe contraception for 6 months after PDT )
  • accompanying/complicating disease with very poor prognosis (expected survival < 6 weeks),
  • proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)

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: Intervention
Drug: Temoporfin

Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min.

Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan

Other Names:
  • Foscan
  • Meso-tetrahydroxyphenyl Chlorin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
Time Frame: post treatment
post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival time, overall survival time
Time Frame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
Toxicity using WHO criteria and criteria for local toxicity in the biliary system
Time Frame: Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention

Collaborators and Investigators

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

Sponsor

University of Salzburg

Collaborators

Biolitec Pharma Ltd.

Investigators

  • Principal Investigator: Frieder Berr, Prof., MD, Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria
  • Principal Investigator: Lohse A, Prof., MD, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany

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

January 1, 2006

Primary Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2009

Last Update Submitted That Met QC Criteria

November 16, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Foscan 1/2005
  • EUDRA CT 2005-004866-17

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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