Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer
|Superficial Bladder Cancer||Procedure: Whole bladder laser light treatment as an alternative to radical cystectomy Drug: Photofrin||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer|
- Dose Limiting Toxicity [ Time Frame: 18 months ]
- Disease progression [ Time Frame: 18 months ]
|Study Start Date:||February 2005|
|Study Completion Date:||March 2011|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: A single arm, non-randomized Phase II Study
Non-Randomized Phase II,Single Arm Study evaluating the efficacy of whole bladder photodynamic therapy as an alternative to radical cystectomy.
Procedure: Whole bladder laser light treatment as an alternative to radical cystectomy
The drug,Photofrin,at the dose of 1.5 mg/kg is infused intravenously two days prior to performing whole bladder laser light (630 nm) treatment.Drug: Photofrin
The drug,Photofrin,at the dose of 1.5 mg/kg is infused intravenously two days prior to performing whole bladder laser light (630 nm) treatment.
Other Name: Porfimer Sodium, Photofrin,photosensiter,dye
Patient Evaluation and Treatment:
- Patients will sign an IRB-approved informed consent form
Initial patient assessments will include:
- History and physical.
- clinical profile
- upper urinary tract imaging (if clinically indicated)
- urinary symptoms assessment
- 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
Decisions to administer a second or third WBPDT will be based upon urological and medical assessment of the individual patient and not necessarily dependent upon Dose Limiting Toxicities (DLT) or early stopping endpoints (although such information may be taken into account in the individual patient assessment). Patients experiencing DLT may continue WBPDT at the investigator's discretion at the same or reduced doses of Porfimer Sodium and/or light.
The following will be considered Dose Limiting Toxicities (DLT):
- Urinary symptoms grade 3, or more over 12 weeks duration (see section 7 for toxicity grading)
- Loss of > 50% of baseline bladder volume
- Clinical decision of investigator or patient to discontinue due to toxicity.
Efficacy will be assessed on the basis of the following criteria:
- Complete Response: cystoscopy with biopsy and/or cytology without evidence of cancer.
- Partial Response: normal cystoscopy and biopsies, if obtained, but persistent positive or suspicious cytology localized to the bladder; or, for patients with CIS, > 50% reduction in extent of CIS.
- Persistent/Recurrent Disease: persistent or recurrent cancer of the same or lesser stage and grade as at enrollment without obvious increase in tumor burden.
- Progression: cancer of any greater stage or grade than at enrollment or obvious increase in tumor burden.
Referred patients will undergo post-PDT cystoscopy by the referring Urologists, who will transmit the results to the study site in Gainesville,Fl.
- Symptoms will be assessed for one month following each WBPDT by weekly telephone contact.
- Urine and blood for cytokines will be obtained before each treatment and possibly twice afterwards and stored -80oF for analysis later.
- Biopsy specimen samples from tumor and normal bladder may be obtained at cystoscopy and stored for later analysis for biomarkers.
- Patients will be followed for toxicity, disease status, urinary tract symptoms, and survival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322699
|United States, Florida|
|Malcom Randall NF/SG Veterans Administration Health System|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Unyime O Nseyo, M.D.||NF/SGVAHS|