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

Phase 1
18 Years
Not Enrolling
Intermediate or High-risk Bladder Cancer

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Trial Information

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

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.

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

- Women of child-bearing potential.

- Conditions associated with a risk of poor protocol compliance

Type of Study:


Study Design:

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

Outcome Measure:

Number of patients with adverse events

Outcome Description:

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)

Safety Issue:


Principal Investigator

Dirk Zaak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Urology Department, Medizinische Fakult├Ąt der LMU Muenchen


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

PC B251/03



Start Date:

March 2005

Completion Date:

August 2008

Related Keywords:

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