Carcinoma, Transitional CellPhase 1NCT00109655
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
A Phase 1 study testing Oncolytic adenovirus (serotype 5) - CG0070 in people with Carcinoma, Transitional Cell and Bladder Neoplasms, run by Cell Genesys at 10 sites in 2 countries.
Trial summary
The main purpose of this research study is to evaluate the safety and dosing of CG0070. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Transitional Cell, Bladder Neoplasms
- What is being tested?
- Oncolytic adenovirus (serotype 5) - CG0070
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Apr 2005to Sep 2010
- 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
- High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease.
- Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment
- ECOG performance status 0-1
- Adequate bone marrow, renal, liver and coagulation function
Who cannot join
- Pregnant or nursing
- HIV positive
- Use of anticoagulants such as coumadin or heparin
- History of bleeding disorder
- Active systemic autoimmune disease or chronic immunodeficiency
- Prior gene therapy
- Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
New York Oncology Hematology
Albany, New York, 12208
Billings Clinic
Billings, Montana, 59107
Mary Crowley Medical Research Center
Dallas, Texas, 75246
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Baylor College of Medicine
Houston, Texas, 77030
Columbia University
New York, New York, 10032
BCG Oncology
Phoenix, Arizona, 85032
UCSF Comprehensive Cancer Center
San Francisco, California, 94143
Canada2 sites
Male/Female Health and Research Centre
Barrie, Ontario, L4M 7G1
The Fe/Male Health Centre
Oakville, Ontario, L6H 3P1
About this study
Official title: A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
Read the detailed description
Cohorts of three to six patients will be assigned to receive intravesical (into the bladder) administration of CG0070 either Weekly or Every 4 Weeks for up to a total of 6 doses.
- Conditions
- Carcinoma, Transitional Cell, Bladder Neoplasms
- Being tested
- Oncolytic adenovirus (serotype 5) - CG0070
- Keywords
- Superficial Transitional Cell Carcinoma, Bacillus Calmette-Guerin (BCG), Superficial Bladder Cancer, Gene Therapy, Vaccine, Adenovirus, Carcinoma in situ
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Adenoviridae Infections, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncolytic adenovirus (serotype 5) - CG0070Biological
Intravesical administration of CG0070 (in suspension) directly into the bladder
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Oncolytic adenovirus (serotype 5) - CG0070 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration
Measured: Study End
Secondary outcomes (1)
Assessment of the amount of CG0070 in the urine and blood over time by PCR
Measured: Study End
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2005 (estimated)
- Study startApr 2005
- Primary completionOct 2008 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Transitional CellStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cell Genesys
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109655
- Sponsor's protocol ID
- V-0046
- Status last verified
- Oct 2008
- First submitted
- 2 May 2005
- Last updated
- 3 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure
- ClinicalTrials.gov ID
- NCT00109655
- Acronym / sponsor ID
- V-0046
- Conditions
- Carcinoma, Transitional Cell, Bladder Neoplasms
- Keywords
- Superficial Transitional Cell Carcinoma, Bacillus Calmette-Guerin (BCG), Superficial Bladder Cancer, Gene Therapy, Vaccine, Adenovirus, Carcinoma in situ
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cell GenesysIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 3 May 2005 (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 main purpose of this research study is to evaluate the safety and dosing of CG0070.
Detailed description
Cohorts of three to six patients will be assigned to receive intravesical (into the bladder) administration of CG0070 either Weekly or Every 4 Weeks for up to a total of 6 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Oncolytic adenovirus (serotype 5) - CG0070 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease.
- Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment
- ECOG performance status 0-1
- Adequate bone marrow, renal, liver and coagulation function
Key exclusion criteria (7 listed)
- Pregnant or nursing
- HIV positive
- Use of anticoagulants such as coumadin or heparin
- History of bleeding disorder
- Active systemic autoimmune disease or chronic immunodeficiency
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 |
|---|---|---|
| Oncolytic adenovirus (serotype 5) - CG0070Intravesical administration of CG0070 (in suspension) directly into the bladder | Biological | 1 |
Primary outcome
Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration
Time frame: Study End
1 secondary outcome
Assessment of the amount of CG0070 in the urine and blood over time by PCR
Time frame: Study End
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2008.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oncolytic adenovirus (serotype 5) - CG0070 in people with Carcinoma, Transitional Cell and Bladder Neoplasms, run by Cell Genesys at 10 sites in 2 countries.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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 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?
Results are not available in the source record.
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?
Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration (time frame: Study End). 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 3 Oct 2008.