Hexvix Photodynamic Therapy in Patients With Bladder Cancer

NCT ID: NCT01303991

Last Updated: 2011-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-08-31

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.

Conditions

Intermediate or High-risk Bladder Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hexvix PDT

Group Type: EXPERIMENTAL

Hexvix PDT with Karl Storz T-Light

Intervention Type: OTHER

Interventions

Hexvix PDT with Karl Storz T-Light

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karl Storz

UNKNOWN

Sponsor Role: collaborator

Photocure

INDUSTRY

Sponsor Role: lead

Principal Investigators

Dirk Zaak, MD

Role: PRINCIPAL_INVESTIGATOR

Urology Department, Medizinische Fakultät der LMU Muenchen

Other Identifiers

PC B251/03

Identifier Type: -

Identifier Source: org_study_id