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Hexvix Photodynamic Therapy in Patients With Bladder Cancer

Sponsor
Photocure (Industry)
Overall Status
Completed
CT.gov ID
NCT01303991
Collaborator
Karl Storz (Other)
17
Enrollment
1
Arm
41
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
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 :
Mar 1, 2005
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hexvix PDT

Other: Hexvix PDT with Karl Storz T-Light

Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Photocure
  • Karl Storz

Investigators

  • Principal Investigator: Dirk Zaak, MD, Urology Department, Medizinische Fakultät der LMU Muenchen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01303991
Other Study ID Numbers:
  • PC B251/03
First Posted:
Feb 25, 2011
Last Update Posted:
Feb 25, 2011
Last Verified:
Feb 1, 2011
Additional relevant MeSH terms:
Urinary Bladder Neoplasms

Study Results

No Results Posted as of Feb 25, 2011