NCT00322699CompletedPhase 1
Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer
North Florida/South Georgia Veterans Health System1 site in 1 country22 target enrollmentStarted: February 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Dose Limiting Toxicity
Study Overview
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 (non-muscle invasive) in those patients who have failed or are not candidates for conventional intravesical therapy.
Detailed Description
Patient Evaluation and Treatment:
- Patients will sign an IRB-approved informed consent form
- Initial patient assessments will include:
- eligibility
- History and physical.
- clinical profile
- upper urinary tract imaging (if clinically indicated)
- urinary symptoms assessment
WBPDT Treatment:
- Porfimer Sodium (Photofrin) 1.5 mg/kg iv followed 2 days later by whole bladder laser light at 630 nm with target light doses of 1200 Joules (+/-100Joules)
- Patients will undergo three sequential WBPDT treatments
- Treatments will occur at least three months apart
- All WBPDT treatments will occur within 12 months
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 >
- •Patients must sign an informed consent form in accordance with the Institution's Review Board and FDA 21 CFR Part
- •Female patients must be practicing a medically acceptable form of birth control or be sterile or postmenopausal.
Exclusion Criteria
- •Pregnant or nursing mother.
- •Known hypersensitivity to porphyrins.
Arms & Interventions
A single arm, non-randomized Phase II Study
Experimental
Non-Randomized Phase II,Single Arm Study evaluating the efficacy of whole bladder photodynamic therapy as an alternative to radical cystectomy.
Intervention: Whole bladder laser light treatment as an alternative to radical cystectomy (Procedure)
A single arm, non-randomized Phase II Study
Experimental
Non-Randomized Phase II,Single Arm Study evaluating the efficacy of whole bladder photodynamic therapy as an alternative to radical cystectomy.
Intervention: Photofrin (Drug)
Outcomes
Primary Outcomes
Dose Limiting Toxicity
Time Frame: 18 months
Secondary Outcomes
- Disease progression(18 months)
Investigators
Unyime O. Nseyo, MD
PHYSICIAN
North Florida/South Georgia Veterans Health System
Study Sites (1)
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