Status:
COMPLETED
Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer
Lead Sponsor:
North Florida/South Georgia Veterans Health System
Collaborating Sponsors:
North Florida Foundation for Research and Education
Axcan Pharma
Conditions:
Superficial Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This protocol is evaluating efficacy and toxicity of three sequential whole bladder photodynamic treatment with Photofrin and red laser light (630 nm) in the management of superficial bladder cancer (...
Detailed Description
Patient Evaluation and Treatment: 1. Patients will sign an IRB-approved informed consent form 2. Initial patient assessments will include: * eligibility * History and physical. * clinical p...
Eligibility Criteria
Inclusion
- Pathological diagnosis of bladder cancer, non muscle invasive
- Recurrent after at least one course of standard intravesical therapy after transurethral resection (TURBT).
- Maximum debulking of tumor by TURBT/fulguration
- One or more of the following:
- Contraindications to conventional intravesical therapy, including patient's refusal.
- Positive or suspicious urine cytology localized to the bladder
- Prior intravesical therapy and persistent atypia.
- Premalignant (diffuse squamous metaplasia or malakoplakia) lesions.
- Bladder capacity greater or equal to 150 cc.
- No contraindications to an appropriate anesthesia or analgesia.
- Karnofsky's performance status \> 50.
- Patients must sign an informed consent form in accordance with the Institution's Review Board and FDA 21 CFR Part 50.
- Female patients must be practicing a medically acceptable form of birth control or be sterile or postmenopausal.
Exclusion
- Pregnant or nursing mother.
- Known hypersensitivity to porphyrins.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00322699
Start Date
February 1 2005
End Date
March 1 2011
Last Update
October 26 2012
Active Locations (1)
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1
Malcom Randall NF/SG Veterans Administration Health System
Gainesville, Florida, United States, 32608