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

Non-curative Resectable Bile Duct Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01016002
• Other study ID #: Foscan 1/2005
• Secondary ID: EUDRA CT 2005-00
• Status: Recruiting
• Phase: Phase 2
• First received: November 16, 2009
• Last updated: November 16, 2009
• Start date: January 2006

Study information

• Verified date: November 2009
• Source: University of Salzburg
• Contact: Frieder Berr, Prof., MD
• Phone: (43-) 662-4482
• Email: f.berr[@]salk.at
• Is FDA regulated: No
• Health authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Carcinoma
• Carcinoma, Ductal
• Non-curative Resectable Bile Duct Carcinoma

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

Locations

Country	Name	City	State
Austria	Department of Internal Medicine I, Paracelsus Medical University Salzburg	Salzburg
Germany	Internal Medicine Dept., University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Salzburg	Biolitec Pharma Ltd.

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT		post treatment	No
Secondary	Progression-free survival time, overall survival time		Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention	Yes
Secondary	Toxicity using WHO criteria and criteria for local toxicity in the biliary system		Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention	Yes