Bladder CancerPhase 1/2NCT00891748
Safety Study on AdCD40L Gene Therapy for Bladder Cancer
A Phase 1/2 study testing AdCD40L in people with Bladder Cancer, run by Uppsala University at 1 site in Sweden.
Trial summary
The study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance, toxicity and immunological parameters will be evaluated during and post treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- AdCD40L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2006to Oct 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven diagnosis of transitional cell carcinoma of the bladder
- ECOG 0-2
- 18 years of age or older
- signed informed consent
- for the Phase I part: patient scheduled for cystectomy
Who cannot join
- Woman of childbearing potential (fertile woman)
- Other malignancy within 5 years of study, except for non-melanoma skin cancer
- Metastatic disease
- Previous exposure to any intravesical therapy for bladder cancer: within 3 months for chemotherapy and within 6 months for BCG therapy.
- Previous pelvic radiation or treatment with any cytotoxic, immunologic or chemotherapeutic agent for non-malignant conditions within 5 years of study.
- Clinically abnormal hepatic, renal or bone marrow function, or coagulation disorders in the opinion of the investigator.
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- Chronic urinary tract infections.
- Serous infection of G.U. surgery, except for bladder cancer, within 1 month of study requiring more than 3 days of hospital care.
- Vesical capacity <150mL and/or vesical obstruction with residual >150 mL after spontaneous voiding.
- Previous exposure to any experimental drug within 3 months from enrolment.
- Any significant medical or psychiatric illness that would prevent the patient from giving informed consent of from following the study procedures.
- Patients who presently have urothelial cell carcinoma of the upper G.U. tract
- Patients with systemic autoimmune disease
- Patients that do not consent to that tissue and blood samples are stored in a biobank
- Treatment with systemically administered corticosteroids and NSAID within 4 weeks prior to first study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma
The study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance, toxicity and immunological parameters will be evaluated during and post treatment.
- Conditions
- Bladder Cancer
- Being tested
- AdCD40L
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdCD40LGenetic
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter
| Study group | Role | What they receive |
|---|---|---|
| AdCD40L | Experimental | Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter. Receives: Genetic: AdCD40L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Measured: Continously during therapy and at follow up 30d
Secondary outcomes (1)
Inflammation
Measured: Continously during treatment and at follow up 30d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startNov 2006
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Investigators
- Per-Uno Malmstrom, MD PhD, Principal investigator, Uppsala University Hospital, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891748
- Sponsor's protocol ID
- 001:CD40L
- Other IDs
- 2006-000985-34
- Status last verified
- Apr 2009
- First submitted
- 30 Apr 2009
- Last updated
- 18 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma
- ClinicalTrials.gov ID
- NCT00891748
- Acronym / sponsor ID
- 001:CD40L
- Conditions
- Bladder Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- Nov 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 1 May 2009 (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 study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance, toxicity and immunological parameters will be evaluated during and post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AdCD40L | Experimental | Genetic: AdCD40LAdenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven diagnosis of transitional cell carcinoma of the bladder
- ECOG 0-2
- 18 years of age or older
- signed informed consent
- for the Phase I part: patient scheduled for cystectomy
Key exclusion criteria (15 listed)
- Woman of childbearing potential (fertile woman)
- Other malignancy within 5 years of study, except for non-melanoma skin cancer
- Metastatic disease
- Previous exposure to any intravesical therapy for bladder cancer: within 3 months for chemotherapy and within 6 months for BCG therapy.
- Previous pelvic radiation or treatment with any cytotoxic, immunologic or chemotherapeutic agent for non-malignant conditions within 5 years of study.
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 |
|---|---|---|
| AdCD40LAdenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter | Genetic | AdCD40L |
Primary outcome
Toxicity
Time frame: Continously during therapy and at follow up 30d
1 secondary outcome
Inflammation
Time frame: Continously during treatment and at follow up 30d
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 18 Jan 2010.
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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.
Per-Uno Malmstrom, MD PhD principal investigator
Uppsala University Hospital, Uppsala, Sweden
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 AdCD40L in people with Bladder Cancer, run by Uppsala University at 1 site in Sweden.
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 5 inclusion and 15 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 18 Jan 2010. 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 Sweden. 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?
Toxicity (time frame: Continously during therapy and at follow up 30d). 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 18 Jan 2010.