Hexvix Photodynamic Therapy in Patients With Bladder Cancer

Phase 1

Completed

• Conditions: Intermediate or High-risk Bladder Cancer
• Interventions: Other: Hexvix PDT with Karl Storz T-Light

• Registration Number: NCT01303991
• Lead Sponsor: Photocure

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2011-02
• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-24
• Last Update Submitted: 2011-02-24
• Study First Posted: 2011-02-25
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hexvix PDT	Hexvix PDT with Karl Storz T-Light	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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