Bladder CancerPhase 1NCT00880854
Study of CP-675,206 in Bacillus Calmette-Guerin (BCG)-Resistant Bladder Cancer
A Phase 1 study testing BCG and CP-675,206 in people with Bladder Cancer, run by University of Wisconsin, Madison.
Trial summary
The purpose of this study is to find out the highest safe dose of the investigational drug CP-675,206 when given in combination with BCG therapy to patients who have experienced recurrent superficial bladder cancer after standard BCG 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?
- BCG and CP-675,206
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Feb 2011
- 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
- Histologic diagnosis of transitional cell cancer of the bladder must have completed a transurethral resection of all visible bladder tumors, and have completed two previous 6-week courses with intravesical BCG.
- Evidence of disease recurrence within 1 year of previous BCG treatment
- Tumor tissue must be available from biopsy for study related immunohistochemical analysis
- If sexually active must use reliable form of contraception while on study and for 4 weeks after last treatment
- ECOG performance status of <2
- Life expectancy of at least 6 months
- Adequate hematologic, renal and liver function
- Informed consent
Who cannot join
- No evidence of immunosuppression or treated with immunosuppressive therapy within 6 months
- No prior radiation to the pelvis
- No gross hematuria within 1 week prior to planned week 1 treatment
- Cannot have previous intolerance to BCG
- Cannot be seropositive for HIV, hepatitis B(HBV) or hepatitis C(HCV) per patient history
- No evidence of metastatic disease
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- No prior treatment with anti-CTLA-4 monoclonal antibody
- Can not be pregnant or lactating
- No history of autoimmune disorder
- No history of thyroid or adrenal insufficiency
- No history of inflammatory bowel conditions, including diverticulitis, ulcerative colitis, Crohn's or celiac disease, intractable urinary tract infection
About this study
Official title: Phase I Dose-escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) for Patients With BCG-resistant Localized Transitional Cell Carcinoma of the Bladder
The purpose of this study is to find out the highest safe dose of the investigational drug CP-675,206 when given in combination with BCG therapy to patients who have experienced recurrent superficial bladder cancer after standard BCG treatment.
In addition, the study will look to see if taking CP 675,206 generates an immune response and evaluate how the drug affects superficial bladder cancer.
- Conditions
- Bladder Cancer
- Being tested
- BCG and CP-675,206
- Keywords
- bladder cancer, BCG-resistant localized transitional cell of the bladder
- 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.
BCG and CP-675,206Drug
Also called Bacille Calmette-Guerin (BCG), Tremelimumab
Dose level -1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 3 mg/kg I.V. week 3, week 15
Dose level 1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 6 mg/kg I.V. week 3, week 15
Dose level 2: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 10 mg/kg IV week 3, week 15
Dose level 3: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 15 mg/kg IV week 3, week 15
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 in combination with CP-675,206 I.V. week 3, week 1 Receives: Drug: BCG and CP-675,206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ
Measured: 24 months
Secondary outcomes (5)
To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses
Measured: 24 months
To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes
Measured: 24 months
To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses
Measured: 24 months
To determine the 1-year recurrence-free survival
Measured: 24 months
To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2011
Why it stopped: Lack of accrual
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 University of Wisconsin, MadisonThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Douglas G McNeel, M.D., Ph.D., Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880854
- Sponsor's protocol ID
- CO08807
- Other IDs
- NCI-2011-03676, H-2008-0227, A534260, SMPH/MEDICINE/MEDICINE*H
- Status last verified
- Nov 2019
- First submitted
- 13 Apr 2009
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) for Patients With BCG-resistant Localized Transitional Cell Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT00880854
- Acronym / sponsor ID
- CO08807
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, BCG-resistant localized transitional cell of the bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2009
- Primary completion
- Feb 2011 (actual)
- First posted
- 14 Apr 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 purpose of this study is to find out the highest safe dose of the investigational drug CP-675,206 when given in combination with BCG therapy to patients who have experienced recurrent superficial bladder cancer after standard BCG treatment.
In addition, the study will look to see if taking CP 675,206 generates an immune response and evaluate how the drug affects superficial bladder cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BCG and CP-675,206BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 in combination with CP-675,206 I.V. week 3, week 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologic diagnosis of transitional cell cancer of the bladder must have completed a transurethral resection of all visible bladder tumors, and have completed two previous 6-week courses with intravesical BCG.
- Evidence of disease recurrence within 1 year of previous BCG treatment
- Tumor tissue must be available from biopsy for study related immunohistochemical analysis
- If sexually active must use reliable form of contraception while on study and for 4 weeks after last treatment
- ECOG performance status of <2
Key exclusion criteria (11 listed)
- No evidence of immunosuppression or treated with immunosuppressive therapy within 6 months
- No prior radiation to the pelvis
- No gross hematuria within 1 week prior to planned week 1 treatment
- Cannot have previous intolerance to BCG
- Cannot be seropositive for HIV, hepatitis B(HBV) or hepatitis C(HCV) per patient history
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 |
|---|---|---|
| BCG and CP-675,206Also: Bacille Calmette-Guerin (BCG), TremelimumabDose level -1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 3 mg/kg I.V. week 3, week 15 Dose level 1: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 6 mg/kg I.V. week 3, week 15 Dose level 2: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 10 mg/kg IV week 3, week 15 Dose level 3: BCG 81 mg intravesical weekly x 6 beginning on week 1, and weekly x 3 beginning at week 15 CP-675,206 15 mg/kg IV week 3, week 15 | Drug | 1 |
Primary outcome
To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ
Time frame: 24 months
5 secondary outcomes
To determine whether patients treated with CP-675,206 in combination with BCG develop cancer antigen-specific systemic immune responses
Time frame: 24 months
To determine whether patients treated with CP-675,206 in combination with BCG develop an increase in tumor-infiltrating lymphocytes
Time frame: 24 months
To determine whether patients treated with CP-675,206 in combination with BCG develop pathological and cytological complete responses
Time frame: 24 months
To determine the 1-year recurrence-free survival
Time frame: 24 months
To determine a recommended dose and schedule for phase II trial evaluation based on the maximum tolerated dose
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink 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.
Douglas G McNeel, M.D., Ph.D. principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCG and CP-675,206 in people with Bladder Cancer, run by University of Wisconsin, Madison.
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 8 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: withdrawn, as of the sponsor's last update on 15 Nov 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
To determine the safety of CP-675,206 when delivered in combination with BCG in patients with BCG-resistant bladder carcinoma in situ (time frame: 24 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 15 Nov 2019.