Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 10:56 AM
Study NCT ID:
NCT03177460
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2017-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Pilot Presurgical Study of Daratumumab (CD38 Antagonist) or JNJ-40346527 in Men With High-Risk Localized Prostate Cancer Followed by Radical Prostatectomy
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects of daratumumab or FMS inhibitor JNJ-40346527 before surgery in treating patients with high-risk prostate cancer that can be removed by surgery and has not spread to other parts of the body or has spread to nearby tissue or lymph nodes. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spreadFMS inhibitor JNJ-40346527 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving daratumumab or FMS inhibitor JNJ-40346527 before surgery may work better in treating patients with prostate cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. Safety and tolerability of therapy with the study drugs in men with high-risk localized prostate cancer.
SECONDARY OBJECTIVES:
I. To assess the proportion of patients who achieve pathological complete response (CR) with the study drugs in men with high-risk localized prostate cancer.
EXPLORATORY OBJECTIVES:
I. To study immunological changes in tumor tissues and peripheral blood in response to the study drugs in men with high-risk localized prostate cancer.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM A: Patients receive daratumumab intravenously (IV) over 4-8 hours once weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy during week 6.
ARM B: Patients receive FMS inhibitor JNJ-40346527 orally (PO) twice daily (BID) for 4-5 weeks in the absence of disease progression or unacceptable toxicity. After a 3 day wash-out period, patients undergo radical prostatectomy.
After completion of study treatment, patients are followed up at week 18.
I. Safety and tolerability of therapy with the study drugs in men with high-risk localized prostate cancer.
SECONDARY OBJECTIVES:
I. To assess the proportion of patients who achieve pathological complete response (CR) with the study drugs in men with high-risk localized prostate cancer.
EXPLORATORY OBJECTIVES:
I. To study immunological changes in tumor tissues and peripheral blood in response to the study drugs in men with high-risk localized prostate cancer.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM A: Patients receive daratumumab intravenously (IV) over 4-8 hours once weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy during week 6.
ARM B: Patients receive FMS inhibitor JNJ-40346527 orally (PO) twice daily (BID) for 4-5 weeks in the absence of disease progression or unacceptable toxicity. After a 3 day wash-out period, patients undergo radical prostatectomy.
After completion of study treatment, patients are followed up at week 18.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01179 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2017-0103 | OTHER | M D Anderson Cancer Center | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |