Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170157
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2005-09-13
Brief Title:
Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase II Immunotherapeutic Trial Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-01
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:
RATIONALE Androgens can cause the growth of prostate cancer cells Antihormone therapy such as leuprolide acetate goserelin flutamide or bicalutamide may lessen the amount of androgens made by the body Monoclonal antibodies such as ipilimumab can block cancer growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry cancer-killing substances to them Giving antihormone therapy together with ipilimumab may kill more tumor cells
PURPOSE This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer
PURPOSE This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer
Detailed Description:
OBJECTIVES
I To generally test whether the addition of CTLA-4 blockade can enhance clinical treatment response in advance prostate cancer patients compared with treatment with AA therapy alone
II To specifically examine whether concomitant AA therapy MDX-010 can be used to prolong the progression-free interval in advanced prostate cancer patients compared with inductive short-term AA therapy alone
III To specifically examine whether concomitant AA therapy MDX-010 can be used to enhance initial PSA responses in advanced prostate cancer patients compared with inductive short-term AA therapy alone
IV To specifically examine whether delayed MDX-010 can be used to induce PSA response in patients experiencing disease progression following cessation of short-term AA therapy
V To generally examine whether MDX-010 enhances host immune response that might be involved in conferring treatment advantages to patients receiving AA therapy
VI To specifically examine whether MDX-010 potentiates T-cell responses in advanced prostate cancer patients initiating inductive short-term AA therapy
VII To further examine whether treatment induced T-cell responses correlate with clinical response to treatment
VIII To examine whether short-term AA there - MDX-010 induces the appearance of newly emigrated T or immature andor B cells
OUTLINE
Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive either leuprolide acetate intramuscularly IM or goserelin subcutaneously SC on days 0 28 and 56 Patients also receive oral flutamide three times daily or oral bicalutamide once daily Treatment with antiandrogen AA therapy continues for 3 months 3-4 months for patients who initiated AA therapy 21 days prior to enrollment in the absence of disease progression or unacceptable toxicity Patients receive ipilimumab IV over 90 minutes on day 7 within 7-28 days post-initiation of AA therapy for patients who initiated AA therapy 21 days prior to enrollment of AA therapy
Arm II Patients receive AA therapy as in arm I Patients may crossover to arm II in the case of disease progression
After completion of study treatment patients are followed periodically
I To generally test whether the addition of CTLA-4 blockade can enhance clinical treatment response in advance prostate cancer patients compared with treatment with AA therapy alone
II To specifically examine whether concomitant AA therapy MDX-010 can be used to prolong the progression-free interval in advanced prostate cancer patients compared with inductive short-term AA therapy alone
III To specifically examine whether concomitant AA therapy MDX-010 can be used to enhance initial PSA responses in advanced prostate cancer patients compared with inductive short-term AA therapy alone
IV To specifically examine whether delayed MDX-010 can be used to induce PSA response in patients experiencing disease progression following cessation of short-term AA therapy
V To generally examine whether MDX-010 enhances host immune response that might be involved in conferring treatment advantages to patients receiving AA therapy
VI To specifically examine whether MDX-010 potentiates T-cell responses in advanced prostate cancer patients initiating inductive short-term AA therapy
VII To further examine whether treatment induced T-cell responses correlate with clinical response to treatment
VIII To examine whether short-term AA there - MDX-010 induces the appearance of newly emigrated T or immature andor B cells
OUTLINE
Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive either leuprolide acetate intramuscularly IM or goserelin subcutaneously SC on days 0 28 and 56 Patients also receive oral flutamide three times daily or oral bicalutamide once daily Treatment with antiandrogen AA therapy continues for 3 months 3-4 months for patients who initiated AA therapy 21 days prior to enrollment in the absence of disease progression or unacceptable toxicity Patients receive ipilimumab IV over 90 minutes on day 7 within 7-28 days post-initiation of AA therapy for patients who initiated AA therapy 21 days prior to enrollment of AA therapy
Arm II Patients receive AA therapy as in arm I Patients may crossover to arm II in the case of disease progression
After completion of study treatment patients are followed periodically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA015083 | NIH | Mayo Clinic | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2009-01214 | REGISTRY | None | None |
| MC0253 | OTHER | None | None |