Neoadjuvant Ipilimumab in Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01194271 |
Recruitment Status
:
Completed
First Posted
: September 2, 2010
Last Update Posted
: August 22, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | September 1, 2010 | |||
First Posted Date ICMJE | September 2, 2010 | |||
Last Update Posted Date | August 22, 2016 | |||
Study Start Date ICMJE | September 2010 | |||
Actual Primary Completion Date | October 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Longitudinal Peripheral Blood Values [ Time Frame: Weekly for 8 weeks ] Five immunological variables measured on peripheral blood (pb) samples and tumor tissue samples: (i) effector to regulatory T cell ratio (measured in blood and tumor), (ii) CD4+ICOS+ T cells (measured in blood and tumor), (iii) CD8+ICOS+ T cells (measured in blood and tumor), (iv) NY-ESO-1 antibodies (measured only in blood, not tumor), and (v) absolute lymphocyte count (measured only in blood, not tumor). Measurements based on pb samples weeks 0, 1, 4, 7, and measurements from tumor tissue at week 8.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01194271 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Neoadjuvant Ipilimumab in Prostate Cancer | |||
Official Title ICMJE | A Neoadjuvant Phase IIa Study of Ipilimumab {Formerly Known as MDX-010 (BMS-734016)} Plus Hormone Ablation in Men With Prostate Cancer Followed by Radical Prostatectomy. | |||
Brief Summary | The goal of this clinical research study is to learn how ipilimumab in combination with Lupron (leuprolide acetate) affects the body's own defense (immune) system before having surgery to remove prostate cancer. The safety of the drug combination will also be studied. | |||
Detailed Description | The Study Drugs: Ipilimumab is designed to cause an immune response in your body by blocking 2 specific molecules that usually block an immune response. This may help to kill cancer cells. Leuprolide acetate is designed to lower the level of testosterone (a male hormone) in the blood. This may slow the growth of cancer cells. Study Drug Administration: If you are found to be eligible to take part in this study, you will receive a leuprolide acetate injection in your muscle. This is considered Week 0. One week later, you will begin treatment with ipilimumab. Ipilimumab will be given by vein over 90 minutes during Weeks 1 and 4 (about 21 days apart). During the infusion, your blood pressure will be measured every 30 minutes, and again an hour after you are finished receiving the drug. Study Visits: At Weeks 0, 1, 4 and 7, the following tests and procedures will be performed:
Surgery: About 4 weeks after your second treatment with ipilimumab, you will have surgery to remove your prostate gland. You will be asked to sign a separate consent form that describes the surgery and its risks. A sample of the leftover prostate gland tissue from surgery will be tested for an immune response. On that day, the following tests and procedures will be performed: Between 14 and 24 weeks after your surgery, you will return to the clinic for your post-operative follow-up visit. The following tests and procedures will be performed:
Length of Study: You will only receive 2 treatments with ipilimumab on this study. You will be on study until 24 weeks after surgery. You will be taken off study if intolerable side effects occur, if the disease gets worse, or if the study doctor thinks it is in your best interest to be taken off study. This is an investigational study. Ipilimumab is not FDA approved or commercially available. Ipilimumab is currently being used for research purposes only. Leuprolide acetate is FDA approved for management of metastatic prostate cancer but is not approved for use before definitive surgery. It is commercially available to treat prostate cancer. Up to 20 patients will take part in this study. All will be enrolled at MD Anderson. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | |||
Intervention ICMJE |
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Study Arms | Experimental: Neoadjuvant Ipilimumab
Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
19 | |||
Original Estimated Enrollment ICMJE |
20 | |||
Actual Study Completion Date | October 2015 | |||
Actual Primary Completion Date | October 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01194271 | |||
Other Study ID Numbers ICMJE | 2009-0135 NCI-2010-01974 ( Registry Identifier: NCI CTRP ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | M.D. Anderson Cancer Center | |||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | |||
Collaborators ICMJE | Bristol-Myers Squibb | |||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | |||
Verification Date | August 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |