Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer
Completed · Phase 1/Phase 2
Conditions studied: Superficial Bladder Cancer
In brief
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 (non-muscle invasive) in those patients who have failed or are not candidates for conventional intravesical therapy.
Key facts
- Study ID
- NCT00322699
- Run by
- North Florida/South Georgia Veterans Health System
- People needed
- 22
- Starts
- 2005-02-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2012-10-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Pregnant or nursing mother.
- Known hypersensitivity to porphyrins.
Where it is running
- Malcom Randall NF/SG Veterans Administration Health System — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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