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Hexvix Photodynamic Therapy in Patients With Bladder Cancer

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ClinicalTrials.gov Identifier: NCT01303991
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : February 25, 2011
Sponsor:
Collaborator:
Karl Storz
Information provided by:
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.

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Hexvix PDT Other: Hexvix PDT with Karl Storz T-Light



Primary Outcome Measures :
  1. 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 :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303991


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

Responsible Party: Photocure ASA
ClinicalTrials.gov Identifier: NCT01303991     History of Changes
Other Study ID Numbers: PC B251/03
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: February 2011

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