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

October 25, 2012 updated by: Unyime O. Nseyo, MD, North Florida/South Georgia Veterans Health System
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.

Study Overview

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 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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32608
        • Malcom Randall NF/SG Veterans Administration Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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 Names:
  • Porfimer Sodium, Photofrin,photosensiter,dye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose Limiting Toxicity
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease progression
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Unyime O Nseyo, M.D., NF/SGVAHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 4, 2006

First Submitted That Met QC Criteria

May 4, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

August 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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