Hexvix Photodynamic Therapy in Patients With Bladder Cancer

Intermediate or High-risk Bladder Cancer Clinical Trial

Official title:

A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303991
• Other study ID #: PC B251/03
• Status: Completed
• Phase: Phase 1
• First received: February 18, 2011
• Last updated: February 24, 2011
• Start date: March 2005
• Est. completion date: August 2008

Study information

• Verified date: February 2011
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder.

Description:

Non-muscle invasive bladder cancer is currently treated by transurethral resection (TURB) and/or fulguration. However, recurrence and progression rates following endoscopic treatment of visible lesions are significant. To prevent recurrent and progressive disease, adjuvant intravesical chemotherapy and immunotherapy are applied. There is also increasing interest in new therapeutic strategies such as photodynamic therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged 18 years or above who have given written informed consent.

• Patients with intermediate or high-risk superficial bladder cancer, defined as low-grade early recurrence within 6 months after local chemotherapy or BCG, primary or recurrent high-grade disease (TaG3, TaG3 with CIS or CIS alone) or patients with primary T1G3 who are tumour free at second resection.

Exclusion Criteria:

• Patients with muscle invasive tumour

• Patients with bladder shrinkage

• Patients who have received prior PDT for bladder cancer

• History of T1G3 disease or other indications for cystectomy

• Patient with porphyria

• Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with PDT)

• Patients who have received BCG or chemotherapy within three months prior to Hexvix instillation, except for a single dose of chemotherapy for prevention of seeding after resection

• Known allergy to hexaminolevulinate or a similar compound

• Participation in other clinical studies either concurrently or within the last 30 days

• Women of child-bearing potential.

• Conditions associated with a risk of poor protocol compliance

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermediate or High-risk Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• Hexvix PDT with Karl Storz T-Light

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Photocure	Karl Storz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events	To assess the safety of photodynamic therapy (PDT) using Hexvix and the Karl Storz T-light PDT System in patients with recurrent bladder cancer.; (assessment of adverse events, blood biochemistry, vital signs, urodynamics)		Yes
Secondary	The number of tumour-free patients after 6 months	To assess the efficacy of Hexvix PDT in patients with intermediate and high-risk bladder cancer		No