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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Salzburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Biolitec Pharma ltd., United Drug House, Magna Drive,Dublin 24,Irland
Information provided by:
University of Salzburg
ClinicalTrials.gov Identifier:
NCT01016002
First received: November 16, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Non-curative Resectable Bile Duct Carcinoma
Drug: Temoporfin
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: A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Salzburg:

Primary Outcome Measures:
  • Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT [ Time Frame: post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: January 2006
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016002

Contacts
Contact: Frieder Berr, Prof., MD (43-) 662-4482 ext 2800 f.berr@salk.at
Contact: Lohse A, Prof., MD +49-(0)40-4280 ext 33 910 alohse@uke-uni-hamburg.de

Locations
Austria
Department of Internal Medicine I, Paracelsus Medical University Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Frieder Berr, Prof., MD       f.berr@salk.at   
Principal Investigator: Frieder Berr, Prof., MD         
Germany
Internal Medicine Dept., University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: A. Lohse, Prof., MD       alohse@uke-uni-hamburg.de   
Principal Investigator: A. Lohse, Prof., MD         
Sponsors and Collaborators
University of Salzburg
Biolitec Pharma ltd., United Drug House, Magna Drive,Dublin 24,Irland
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
  More Information

No publications provided

Responsible Party: Prof. Frieder Berr, M.D., Department of Internal Medicine I, Paracelsus Medical University Salzburg, Muellner Hauptstrasse 48, 5020, Salzburg, Austria
ClinicalTrials.gov Identifier: NCT01016002     History of Changes
Other Study ID Numbers: Foscan 1/2005, EUDRA CT 2005-004866-17
Study First Received: November 16, 2009
Last Updated: November 16, 2009
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs

Additional relevant MeSH terms:
Carcinoma
Bile Duct Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Breast Diseases
Skin Diseases
Temoporfin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 01, 2014