Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064129
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2003-07-08
Brief Title:
Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Repetitive Dosing of Anti-CTLA-4 Antibody Ipilimumab in Combination With GM-CSF in Patients With Metastatic Androgen-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial is studying the side effects and best dose of ipilimumab when given with sargramostim in treating patients with metastatic prostate cancer Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 ipilimumab administered with sargramostim GM-CSF in patients with metastatic androgen-independent prostate cancer Phase I II Determine the safety of this regimen in these patients Phase I III Evaluate the efficacy as measured by reduction in PSA associated with combining GM-CSF with CTLA-4 blockade with ipilimumab at a dosage of 3 mgkg given monthly x 6 doses d1 of courses 1-6 Cohort Expansion
SECONDARY OBJECTIVES
I Determine the T-cell immunity and T-cell response in patients treated with this regimen Phase I II Determine the pharmacokinetics of MDX-010 in these patients Phase I III Determine the prostate-specific antigen andor objective responses in patients treated with this regimen Phase I IV Determine the percentages of activated naive and memory T-cells Cohort Expansion V Determine the measurement of T-cell response to describe epitopes from prostate antigens including PSA PSMA and PAP Cohort Expansion VI Quantitate T-cell response to antigens in patients with relevant HLA allele using HLA0201 tetramers Cohort Expansion VII Evaluate the toxicity of this regimen in these patients Cohort Expansion VIII Determine the initial efficacy as measured by reduction in PSA associated with combining GM-CSF with CTLA-4 blockade with ipilimumab at a dosage of 3 mgkg given monthly x 6 doses d1 of courses 1-6 Cohort Expansion IX Determine objective response by post-therapy measurable disease changes using RECIST criteria Cohort Expansion
OUTLINE This is a multicenter dose-escalation study of ipilimumab
Patients receive ipilimumab intravenously IV over 90 minutes on day 1 and sargramostim GM-CSF subcutaneously SC on days 1-14 Treatment repeats every 28 days for 4-6 courses GM-CSF continues beyond 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of ipilimumab until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Some patients undergo blood sample collection periodically for laboratory and pharmacokinetic studies Samples are analyzed for human anti-human antibodies IgG antibodies to ipilimumab semi-quantitative ELISA assay and plasma concentrations of ipilimumab via quantitative ELISA assay
Patients are followed at 30 days
I Determine the maximum tolerated dose of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 ipilimumab administered with sargramostim GM-CSF in patients with metastatic androgen-independent prostate cancer Phase I II Determine the safety of this regimen in these patients Phase I III Evaluate the efficacy as measured by reduction in PSA associated with combining GM-CSF with CTLA-4 blockade with ipilimumab at a dosage of 3 mgkg given monthly x 6 doses d1 of courses 1-6 Cohort Expansion
SECONDARY OBJECTIVES
I Determine the T-cell immunity and T-cell response in patients treated with this regimen Phase I II Determine the pharmacokinetics of MDX-010 in these patients Phase I III Determine the prostate-specific antigen andor objective responses in patients treated with this regimen Phase I IV Determine the percentages of activated naive and memory T-cells Cohort Expansion V Determine the measurement of T-cell response to describe epitopes from prostate antigens including PSA PSMA and PAP Cohort Expansion VI Quantitate T-cell response to antigens in patients with relevant HLA allele using HLA0201 tetramers Cohort Expansion VII Evaluate the toxicity of this regimen in these patients Cohort Expansion VIII Determine the initial efficacy as measured by reduction in PSA associated with combining GM-CSF with CTLA-4 blockade with ipilimumab at a dosage of 3 mgkg given monthly x 6 doses d1 of courses 1-6 Cohort Expansion IX Determine objective response by post-therapy measurable disease changes using RECIST criteria Cohort Expansion
OUTLINE This is a multicenter dose-escalation study of ipilimumab
Patients receive ipilimumab intravenously IV over 90 minutes on day 1 and sargramostim GM-CSF subcutaneously SC on days 1-14 Treatment repeats every 28 days for 4-6 courses GM-CSF continues beyond 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of ipilimumab until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Some patients undergo blood sample collection periodically for laboratory and pharmacokinetic studies Samples are analyzed for human anti-human antibodies IgG antibodies to ipilimumab semi-quantitative ELISA assay and plasma concentrations of ipilimumab via quantitative ELISA assay
Patients are followed at 30 days
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 6032 | OTHER | CTEP | None |
| NCI-2009-00036 | REGISTRY | None | None |
| UCSF-02558 | None | None | None |
| CDR0000309054 | None | None | None |
| NCI-6032 | None | None | None |
| 02558 | OTHER | None | None |