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Hexvix Photodynamic Therapy in Patients With Bladder Cancer

Primary Purpose

Intermediate or High-risk Bladder Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hexvix PDT with Karl Storz T-Light
Sponsored by
Photocure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermediate or High-risk Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hexvix PDT

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    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

    Full Information

    First Posted
    February 18, 2011
    Last Updated
    February 24, 2011
    Sponsor
    Photocure
    Collaborators
    Karl Storz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01303991
    Brief Title
    Hexvix Photodynamic Therapy in Patients With Bladder Cancer
    Official Title
    A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Photocure
    Collaborators
    Karl Storz

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intermediate or High-risk Bladder Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hexvix PDT
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Hexvix PDT with Karl Storz T-Light
    Primary Outcome Measure Information:
    Title
    Number of patients with adverse events
    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)
    Secondary Outcome Measure Information:
    Title
    The number of tumour-free patients after 6 months
    Description
    To assess the efficacy of Hexvix PDT in patients with intermediate and high-risk bladder cancer

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dirk Zaak, MD
    Organizational Affiliation
    Urology Department, Medizinische Fakultät der LMU Muenchen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Hexvix Photodynamic Therapy in Patients With Bladder Cancer

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