Intermediate or High-risk Bladder CancerPhase 1NCT01303991
Hexvix Photodynamic Therapy in Patients With Bladder Cancer
A Phase 1 study testing Hexvix PDT with Karl Storz T-Light in people with Intermediate or High-risk Bladder Cancer, run by Photocure.
Trial summary
The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermediate or High-risk Bladder Cancer
- What is being tested?
- Hexvix PDT with Karl Storz T-Light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Aug 2008
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or above who have given written informed consent.
- Patients with intermediate or high-risk superficial bladder cancer, defined as low-grade early recurrence within 6 months after local chemotherapy or BCG, primary or recurrent high-grade disease (TaG3, TaG3 with CIS or CIS alone) or patients with primary T1G3 who are tumour free at second resection.
Who cannot join
- Patients with muscle invasive tumour
- Patients with bladder shrinkage
- Patients who have received prior PDT for bladder cancer
- History of T1G3 disease or other indications for cystectomy
- Patient with porphyria
- Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with PDT)
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- Patients who have received BCG or chemotherapy within three months prior to Hexvix instillation, except for a single dose of chemotherapy for prevention of seeding after resection
- Known allergy to hexaminolevulinate or a similar compound
- Participation in other clinical studies either concurrently or within the last 30 days
- Women of child-bearing potential.
- Conditions associated with a risk of poor protocol compliance
About this study
Official title: A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer
The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder.
Read the detailed description
Non-muscle invasive bladder cancer is currently treated by transurethral resection (TURB) and/or fulguration. However, recurrence and progression rates following endoscopic treatment of visible lesions are significant. To prevent recurrent and progressive disease, adjuvant intravesical chemotherapy and immunotherapy are applied. There is also increasing interest in new therapeutic strategies such as photodynamic therapy.
- Conditions
- Intermediate or High-risk Bladder Cancer
- Being tested
- Hexvix PDT with Karl Storz T-Light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexvix PDT with Karl Storz T-LightOther
| Study group | Role | What they receive |
|---|---|---|
| Hexvix PDT | Experimental | Not described Receives: Other: Hexvix PDT with Karl Storz T-Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
To assess the safety of photodynamic therapy (PDT) using Hexvix and the Karl Storz T-light PDT System in patients with recurrent bladder cancer.
(assessment of adverse events, blood biochemistry, vital signs, urodynamics)
Secondary outcomes (1)
The number of tumour-free patients after 6 months
To assess the efficacy of Hexvix PDT in patients with intermediate and high-risk bladder cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startMar 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate or High-risk 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karl Storz
- Investigators
- Dirk Zaak, MD, Principal investigator, Urology Department, Medizinische Fakultät der LMU Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303991
- Sponsor's protocol ID
- PC B251/03
- Status last verified
- Feb 2011
- First submitted
- 18 Feb 2011
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer
- ClinicalTrials.gov ID
- NCT01303991
- Acronym / sponsor ID
- PC B251/03
- Conditions
- Intermediate or High-risk Bladder Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Collaborators
- Karl Storz
- Study start
- Mar 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 25 Feb 2011 (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.
The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder.
Detailed description
Non-muscle invasive bladder cancer is currently treated by transurethral resection (TURB) and/or fulguration. However, recurrence and progression rates following endoscopic treatment of visible lesions are significant. To prevent recurrent and progressive disease, adjuvant intravesical chemotherapy and immunotherapy are applied. There is also increasing interest in new therapeutic strategies such as photodynamic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hexvix PDT | Experimental | Other: Hexvix PDT with Karl Storz T-Light |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 18 years or above who have given written informed consent.
- Patients with intermediate or high-risk superficial bladder cancer, defined as low-grade early recurrence within 6 months after local chemotherapy or BCG, primary or recurrent high-grade disease (TaG3, TaG3 with CIS or CIS alone) or patients with primary T1G3 who are tumour free at second resection.
Key exclusion criteria (11 listed)
- Patients with muscle invasive tumour
- Patients with bladder shrinkage
- Patients who have received prior PDT for bladder cancer
- History of T1G3 disease or other indications for cystectomy
- Patient with porphyria
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 |
|---|---|---|
| Hexvix PDT with Karl Storz T-Light | Other | Hexvix PDT |
Primary outcome
Number of patients with adverse events
To assess the safety of photodynamic therapy (PDT) using Hexvix and the Karl Storz T-light PDT System in patients with recurrent bladder cancer. (assessment of adverse events, blood biochemistry, vital signs, urodynamics)
1 secondary outcome
The number of tumour-free patients after 6 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 25 Feb 2011.
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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.
Dirk Zaak, MD principal investigator
Urology Department, Medizinische Fakultät der LMU Muenchen
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hexvix PDT with Karl Storz T-Light in people with Intermediate or High-risk Bladder Cancer, run by Photocure.
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 2 inclusion and 11 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 25 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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?
Number of patients with adverse events. 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 25 Feb 2011.