Prostate CancerPhase 1NCT00702923
CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
A Phase 1 study testing Bicalutamide and CP-675,206 (Tremelimumab), Bicalutamide, CP-675,206 (tremelimumab) and Bicalutamide, CP-675,206 in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with safety the primary endpoint. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Bicalutamide and CP-675,206 (Tremelimumab), Bicalutamide, CP-675,206 (tremelimumab) and Bicalutamide, CP-675,206
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age \& histologic diagnosis of adenocarcinoma of the prostate
- Completed surgery or radiation at least 8 weeks prior to entry with removal of all visible disease
- Clinical Stage D0 prostate cancer with rising PSA and PSA >2ng/ml.
- ECOG performance of <2
- Normal hematologic, renal and liver function
Who cannot join
- Cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy.
- No prior treatment with an LHRH agonist or nonsteroidal antiandrogen such as casodex or flutamide
- No evidence for metastatic disease per bone scan or CT scan of the abdomen and pelvis
- No prior treatment with anti-CTLA 4 monoclonal antibody
- No history of known autoimmune disorder or HIV, hepatitis B or hepatitis C
- No known brain metastases
- No history of inflammatory bowel conditions including diverticulitis, ulcerative colitis, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: Phase I Dose Escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with safety the primary endpoint. Secondary endpoints will be to determine whether prostate associated immune responses are seen, and whether treatment is associated with an increase in PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of six patients will be treated in each dose level. The investigators hypothesize that short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4, and that this will have therapeutic benefit in patients with recurrent prostate cancer.
Read the detailed description
This is an open label, single-center Phase I study. All subjects will receive bicalutamide 150mg orally days 1-28. Subjects will receive CP-675,206 IV over one hour on day 29. Doses will range from 6 mg/kg to 15 mg/kg. This cycle will be repeated once at month 3. Once the maximum tolerated dose has been determined, up to 6 additional subjects will be enrolled.
- Conditions
- Prostate Cancer
- Being tested
- Bicalutamide and CP-675,206 (Tremelimumab), Bicalutamide, CP-675,206 (tremelimumab), Bicalutamide, CP-675,206
- Keywords
- Stage D0 Prostate Cancer, Rising PSA, Casodex, Tremelimumab
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicalutamide and CP-675,206 (Tremelimumab)Drug
Also called Casodex, Tremelimumab
Dose level -1 :
Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 3 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)
Bicalutamide, CP-675,206 (tremelimumab)Drug
Also called Casodex, Tremelimumab
Dose level 1:
Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 6 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)
Bicalutamide, CP-675,206 (Tremelimumab)Drug
Also called Casodex, Tremelimumab
Dose level 2:
Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 10 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)
Bicalutamide, CP-675,206 (Tremelimumab)Drug
Also called Casodex, Tremelimumab
Dose level 3:
Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 15 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7)
Bicalutamide, CP-675,206Drug
Also called Casodex, Tremelimumab
Final Dose Level:
Bicalutamide 150 mg p.o. q.d. day 1-28, day 85-112
At month 9, if evidence of PSA progression:
Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 (MTD dose) I.V. over 1 hour, day 29
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3 Receives: Drug: Bicalutamide and CP-675,206 (Tremelimumab); Drug: Bicalutamide, CP-675,206 (tremelimumab); Drug: Bicalutamide, CP-675,206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Developed Cancer Antigen-specific Immune Responses
Measured: Up to 12 months after treatment with study agent
Secondary outcomes (2)
The Number of Participants With an Increase in PSA Doubling Time
Measured: Up to 18 months after last dose of study agent
Number of Participants With PSA Recurrence.
PSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2011
- Study completionMar 2013
Why it stopped: Enrollment was halted prematurely due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Douglas McNeel, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702923
- Sponsor's protocol ID
- CO07808
- Other IDs
- CO07808, H-2008-0086, NCI-2011-00713, A534260, SMPH/MEDICINE/MEDICINE*H
- Status last verified
- Apr 2014
- First submitted
- 18 Jun 2008
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 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) in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
- ClinicalTrials.gov ID
- NCT00702923
- Acronym / sponsor ID
- CO07808
- Conditions
- Prostate Cancer
- Keywords
- Stage D0 Prostate Cancer, Rising PSA, Casodex, Tremelimumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was halted prematurely due to slow accrual.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 7 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with safety the primary endpoint. Secondary endpoints will be to determine whether prostate associated immune responses are seen, and whether treatment is associated with an increase in PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of six patients will be treated in each dose level. The investigators hypothesize that short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4, and that this will have therapeutic benefit in patients with recurrent prostate cancer.
Detailed description
This is an open label, single-center Phase I study. All subjects will receive bicalutamide 150mg orally days 1-28. Subjects will receive CP-675,206 IV over one hour on day 29. Doses will range from 6 mg/kg to 15 mg/kg. This cycle will be repeated once at month 3. Once the maximum tolerated dose has been determined, up to 6 additional subjects will be enrolled.
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: Bicalutamide and CP-675,206 (Tremelimumab), Drug: Bicalutamide, CP-675,206 (tremelimumab), Drug: Bicalutamide, CP-675,206Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age \& histologic diagnosis of adenocarcinoma of the prostate
- Completed surgery or radiation at least 8 weeks prior to entry with removal of all visible disease
- Clinical Stage D0 prostate cancer with rising PSA and PSA >2ng/ml.
- ECOG performance of <2
- Normal hematologic, renal and liver function
Key exclusion criteria (7 listed)
- Cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy.
- No prior treatment with an LHRH agonist or nonsteroidal antiandrogen such as casodex or flutamide
- No evidence for metastatic disease per bone scan or CT scan of the abdomen and pelvis
- No prior treatment with anti-CTLA 4 monoclonal antibody
- No history of known autoimmune disorder or HIV, hepatitis B or hepatitis C
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 |
|---|---|---|
| Bicalutamide and CP-675,206 (Tremelimumab)Also: Casodex, TremelimumabDose level -1 : Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 3 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7) | Drug | 1 |
| Bicalutamide, CP-675,206 (tremelimumab)Also: Casodex, TremelimumabDose level 1: Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 6 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7) | Drug | 1 |
| Bicalutamide, CP-675,206 (Tremelimumab)Also: Casodex, TremelimumabDose level 2: Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 10 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7) | Drug | 1 |
| Bicalutamide, CP-675,206 (Tremelimumab)Also: Casodex, TremelimumabDose level 3: Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 15 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7) | Drug | 1 |
| Bicalutamide, CP-675,206Also: Casodex, TremelimumabFinal Dose Level: Bicalutamide 150 mg p.o. q.d. day 1-28, day 85-112 At month 9, if evidence of PSA progression: Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 (MTD dose) I.V. over 1 hour, day 29 | Drug | 1 |
Primary outcome
The Number of Participants Who Developed Cancer Antigen-specific Immune Responses
Time frame: Up to 12 months after treatment with study agent
2 secondary outcomes
The Number of Participants With an Increase in PSA Doubling Time
Time frame: Up to 18 months after last dose of study agent
Number of Participants With PSA Recurrence.
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 McNeel, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bicalutamide and CP-675,206 (Tremelimumab), Bicalutamide, CP-675,206 (tremelimumab) and Bicalutamide, CP-675,206 in people with Prostate Cancer, run by University of Wisconsin, Madison 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 5 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: stopped early, as of the sponsor's last update on 21 Nov 2019. 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 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?
Yes. Results are posted in the registry (first posted 7 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants Who Developed Cancer Antigen-specific Immune Responses (time frame: Up to 12 months after treatment with study agent). 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 21 Nov 2019.