Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer

This study has been completed.
Sponsor:
Collaborators:
North Florida Foundation for Research and Education
Axcan Pharma
Information provided by (Responsible Party):
Unyime O. Nseyo, MD, North Florida/South Georgia Veterans Health System
ClinicalTrials.gov Identifier:
NCT00322699
First received: May 4, 2006
Last updated: October 25, 2012
Last verified: August 2011

May 4, 2006
October 25, 2012
February 2005
April 2010   (final data collection date for primary outcome measure)
Dose Limiting Toxicity [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Safety
  • Efficacy
Complete list of historical versions of study NCT00322699 on ClinicalTrials.gov Archive Site
Disease progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Quality of life
Not Provided
Not Provided
 
Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer
Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer

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.

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 profile
    • upper urinary tract imaging (if clinically indicated)
    • urinary symptoms assessment

WBPDT Treatment:

  1. 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)
  2. Patients will undergo three sequential WBPDT treatments
  3. Treatments will occur at least three months apart
  4. 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.

  5. Symptoms will be assessed for one month following each WBPDT by weekly telephone contact.
  6. Urine and blood for cytokines will be obtained before each treatment and possibly twice afterwards and stored -80oF for analysis later.
  7. Biopsy specimen samples from tumor and normal bladder may be obtained at cystoscopy and stored for later analysis for biomarkers.
  8. Patients will be followed for toxicity, disease status, urinary tract symptoms, and survival.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Superficial Bladder Cancer
  • 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
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.
Interventions:
  • Procedure: Whole bladder laser light treatment as an alternative to radical cystectomy
  • Drug: Photofrin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
March 2011
April 2010   (final data collection date for primary outcome measure)

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 > 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 Criteria:

  • Pregnant or nursing mother.
  • Known hypersensitivity to porphyrins.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00322699
WBPDT-577-04
Yes
Unyime O. Nseyo, MD, North Florida/South Georgia Veterans Health System
North Florida/South Georgia Veterans Health System
  • North Florida Foundation for Research and Education
  • Axcan Pharma
Principal Investigator: Unyime O Nseyo, M.D. NF/SGVAHS
North Florida/South Georgia Veterans Health System
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP