Superficial Bladder CancerPhase 1/2NCT00322699
Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer
A Phase 1/2 study testing Whole bladder laser light treatment as an alternative to radical cystectomy and Photofrin in people with Superficial Bladder Cancer, run by North Florida/South Georgia Veterans Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Superficial Bladder Cancer
- What is being tested?
- Whole bladder laser light treatment as an alternative to radical cystectomy and Photofrin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Mar 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- Pregnant or nursing mother.
- Known hypersensitivity to porphyrins.
Trial locations and contacts
1 site in 1 country.
United States1 site
Malcom Randall NF/SG Veterans Administration Health System
Gainesville, Florida, 32608
About this study
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.
Read the 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 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.
- Conditions
- Superficial Bladder Cancer
- Being tested
- Whole bladder laser light treatment as an alternative to radical cystectomy, Photofrin
- Keywords
- Bladder Cancer, Photodynamic Therapy, Photofrin, Photosensitization, Photoradiation
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Urinary Bladder Neoplasms, Photosensitivity Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole bladder laser light treatment as an alternative to radical cystectomyProcedure or surgery
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.
PhotofrinDrug
Also called Porfimer Sodium, Photofrin,photosensiter,dye
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Whole bladder laser light treatment as an alternative to radical cystectomy; Drug: Photofrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: 18 months
Secondary outcomes (1)
Disease progression
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startFeb 2005
- Primary completionApr 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Florida/South Georgia Veterans Health System
- Sponsor type
- University, hospital or other
- Collaborators
- North Florida Foundation for Research and Education, Axcan Pharma
- Responsible party
- Principal investigator, Unyime O. Nseyo, MD, North Florida/South Georgia Veterans Health System
- Investigators
- Unyime O Nseyo, M.D., Principal investigator, NF/SGVAHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322699
- Sponsor's protocol ID
- WBPDT-577-04
- Status last verified
- Aug 2011
- First submitted
- 4 May 2006
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Whole Bladder Photodynamic Therapy (WBPDT) in the Management of Superficial Bladder Cancer
- ClinicalTrials.gov ID
- NCT00322699
- Acronym / sponsor ID
- WBPDT-577-04
- Conditions
- Superficial Bladder Cancer
- Keywords
- Bladder Cancer, Photodynamic Therapy, Photofrin, Photosensitization, Photoradiation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- North Florida/South Georgia Veterans Health SystemUniversity, hospital or other
- Collaborators
- North Florida Foundation for Research and Education, Axcan Pharma
- Study start
- Feb 2005
- Primary completion
- Apr 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single arm, non-randomized Phase II Study | Experimental | Procedure: Whole bladder laser light treatment as an alternative to radical cystectomy, Drug: PhotofrinNon-Randomized Phase II,Single Arm Study evaluating the efficacy of whole bladder photodynamic therapy as an alternative to radical cystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Bladder capacity greater or equal to 150 cc.
Key exclusion criteria (2 listed)
- Pregnant or nursing mother.
- Known hypersensitivity to porphyrins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole bladder laser light treatment as an alternative to radical cystectomyThe 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. | Procedure or surgery | A single arm, non-randomized Phase II Study |
| PhotofrinAlso: Porfimer Sodium, Photofrin,photosensiter,dyeThe 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 | A single arm, non-randomized Phase II Study |
Primary outcome
Dose Limiting Toxicity
Time frame: 18 months
1 secondary outcome
Disease progression
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Unyime O Nseyo, M.D. principal investigator
NF/SGVAHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Whole bladder laser light treatment as an alternative to radical cystectomy and Photofrin in people with Superficial Bladder Cancer, run by North Florida/South Georgia Veterans Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.