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Hexvix Photodynamic Therapy in Patients With Bladder Cancer

This study has been completed.
Sponsor:
Collaborator:
Karl Storz
Information provided by:
PhotoCure
ClinicalTrials.gov Identifier:
NCT01303991
First received: February 18, 2011
Last updated: February 24, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Intermediate or High-risk Bladder Cancer
 Other: Hexvix PDT with Karl Storz T-Light
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PhotoCure:

Primary Outcome Measures:
  • Number of patients with adverse events [ Designated as safety issue: Yes ]

    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:
  • The number of tumour-free patients after 6 months [ Designated as safety issue: No ]
    To assess the efficacy of Hexvix PDT in patients with intermediate and high-risk bladder cancer


Enrollment: 17
Study Start Date: March 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hexvix PDT Other: Hexvix PDT with Karl Storz T-Light

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303991

Sponsors and Collaborators
PhotoCure
Karl Storz
Investigators
Principal Investigator: Dirk Zaak, MD Urology Department, Medizinische Fakultät der LMU Muenchen
  More Information

No publications provided

Responsible Party: Photocure ASA
ClinicalTrials.gov Identifier: NCT01303991     History of Changes
Other Study ID Numbers: PC B251/03
Study First Received: February 18, 2011
Last Updated: February 24, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013