Hexvix Photodynamic Therapy in Patients With Bladder Cancer

Photocure

Status and phase: Completed; Phase 1

Conditions: Intermediate or High-risk Bladder Cancer

Treatments: Other: Hexvix PDT with Karl Storz T-Light

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01303991

PC B251/03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Hexvix PDT

Experimental group

Treatment:

Other: Hexvix PDT with Karl Storz T-Light