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
Recruitment status was Recruiting
Sponsor:
University of Salzburg
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
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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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
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:
|
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:
- 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)
Contacts and Locations
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:
|
Bile Duct Neoplasms Carcinoma 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 Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013