Neoadjuvant Listeria or Daratumumab in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03035357|
Recruitment Status : Withdrawn (PI's Request)
First Posted : January 30, 2017
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Male Genital Organs Prostate Cancer||Drug: Daratumumab||Phase 2|
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive daratumumab by vein over about 1 hour 1 time a week during Weeks 1- 4.
Length of Study:
You may receive up to 4 doses of daratumumab. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the Week 18 visit.
Daratumumab treatment will interfere with blood type testing which is needed before blood transfusions can be given. For this reason, a test to find out your blood type will be performed before you receive daratumumab. You should carry the blood type card with you.
During Weeks 1 and 4:
- You will have a physical exam
- Blood (about 2 tablespoons) will be drawn for routine and blood typing.
During Weeks 2 and 3:
- You will have a physical exam.
- Blood (about 2 tablespoons) will be drawn for routine tests and for blood type testing.
During Week 6 (the week of your surgery):
- You will have a physical exam
- Blood (about 2 tablespoons) will be drawn for routine tests, including measurements of your PSA and testosterone levels. Part of this sample will also be used for blood type testing.
- You will have surgery to remove your prostate. You will sign a separate consent form explaining the procedure and its risks in more detail.
During Week 12, blood (about 2 tablespoons) will be drawn for routine tests, including measurements of your PSA and testosterone levels.
At Week 18, you will come to the clinic and asked about any side effects and how you are doing.
This is an investigational study. Daratumumab is FDA approved and commercially available to treat multiple myeloma (MM). It is considered investigational to use daratumumab in patients with prostate cancer.
The study doctor can explain how the study drug is designed to work.
Up to 15 participants will take part in this study. All will be enrolled at MD Anderson.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Presurgical Study of Daratumumab (CD38 Antagonist) in Men With High-Risk Localized Prostate Cancer Followed by Radical Prostatectomy|
|Estimated Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||March 1, 2019|
Participants receive Daratumumab by vein over about 1 hour 1 time a week during Weeks 1-4.
16 mg/kg by vein once weekly for a total of 4 doses.
- Biomarker Response of CD3 and CD68 Following Treatment with Daratumumab. [ Time Frame: Baseline and at 12 weeks after prostatectomy ]Biomarker response if either CD3 or CD68 has a 1.5 fold increase at prostatectomy (after treatment) compared to baseline (pre-treatment).
- Number of Adverse Events with Daratumumab (Adverse events as per CTCAE v4.03) [ Time Frame: 4 weeks ]Adverse events as per CTCAE v4.03.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035357
|Principal Investigator:||Sumit K. Subudhi, MD, PHD||M.D. Anderson Cancer Center|