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
  Purpose

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.


Condition Intervention Phase
Superficial Bladder Cancer
Procedure: Whole bladder laser light treatment as an alternative to radical cystectomy
Drug: Photofrin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer

Resource links provided by NLM:


Further study details as provided by North Florida/South Georgia Veterans Health System:

Primary Outcome Measures:
  • Dose Limiting Toxicity [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: February 2005
Study Completion Date: March 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322699

Locations
United States, Florida
Malcom Randall NF/SG Veterans Administration Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
North Florida/South Georgia Veterans Health System
North Florida Foundation for Research and Education
Axcan Pharma
Investigators
Principal Investigator: Unyime O Nseyo, M.D. NF/SGVAHS
  More Information

No publications provided

Responsible Party: Unyime O. Nseyo, MD, PHYSICIAN, North Florida/South Georgia Veterans Health System
ClinicalTrials.gov Identifier: NCT00322699     History of Changes
Other Study ID Numbers: WBPDT-577-04
Study First Received: May 4, 2006
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by North Florida/South Georgia Veterans Health System:
Bladder Cancer
Photodynamic Therapy
Photofrin
Photosensitization
Photoradiation

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Trioxsalen
Dihematoporphyrin Ether
Hematoporphyrin Derivative
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014