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

Primary Purpose

Non-curative Resectable Bile Duct Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Temoporfin
Sponsored by
University of Salzburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-curative Resectable Bile Duct Carcinoma

Eligibility Criteria

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

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)

Sites / Locations

  • Department of Internal Medicine I, Paracelsus Medical University SalzburgRecruiting
  • Internal Medicine Dept., University Medical Center Hamburg-EppendorfRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT

Secondary Outcome Measures

Progression-free survival time, overall survival time
Toxicity using WHO criteria and criteria for local toxicity in the biliary system

Full Information

First Posted
November 16, 2009
Last Updated
November 16, 2009
Sponsor
University of Salzburg
Collaborators
Biolitec Pharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01016002
Brief Title
Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
Official Title
A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Salzburg
Collaborators
Biolitec Pharma Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-curative Resectable Bile Duct 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
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Temoporfin
Other Intervention Name(s)
Foscan, Meso-tetrahydroxyphenyl Chlorin
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
Time Frame
post treatment
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension: Bismuth type III or IV ( not resectable with R0-margins ) 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frieder Berr, Prof., MD
Phone
(43-) 662-4482
Ext
2800
Email
f.berr@salk.at
First Name & Middle Initial & Last Name or Official Title & Degree
Lohse A, Prof., MD
Phone
+49-(0)40-4280
Ext
33 910
Email
alohse@uke-uni-hamburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frieder Berr, Prof., MD
Organizational Affiliation
Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lohse A, Prof., MD
Organizational Affiliation
University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine I, Paracelsus Medical University Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frieder Berr, Prof., MD
Email
f.berr@salk.at
First Name & Middle Initial & Last Name & Degree
Frieder Berr, Prof., MD
Facility Name
Internal Medicine Dept., University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Lohse, Prof., MD
Email
alohse@uke-uni-hamburg.de
First Name & Middle Initial & Last Name & Degree
A. Lohse, Prof., MD

12. IPD Sharing Statement

Learn more about this trial

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

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