Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005992
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2000-07-05
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Clinical Trial of Recombinant Prostate Specific Membrane Antigen rPSMA-Loaded Mature Autologous Dendritic Cells CapPVax for the Treatment of Metastatic Horomone Refractory Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2002-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Vaccines made from a persons peripheral stem cells may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Assess the safety of recombinant prostate-specific membrane antigen rPSMA-pulsed autologous dendritic cells CaPVax in patients with metastatic hormone-refractory prostate cancer II Determine the potential clinical response in patients treated with this regimen III Determine the effect of this treatment regimen on pain physical function and quality of life of these patients
OUTLINE This is a dose-escalation multicenter study Patients undergo a delayed hypersensitivity skin test with 3 common recall antigens Autologous dendritic cells DC are pulsed with recombinant prostate-specific membrane antigen rPSMA Patients receive rPSMA-pulsed autologous DC CaPVax intradermally Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of CaPVax until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Quality of life questionnaires are completed five times over the course of the study Patients are followed at 3 months
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
OUTLINE This is a dose-escalation multicenter study Patients undergo a delayed hypersensitivity skin test with 3 common recall antigens Autologous dendritic cells DC are pulsed with recombinant prostate-specific membrane antigen rPSMA Patients receive rPSMA-pulsed autologous DC CaPVax intradermally Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of CaPVax until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Quality of life questionnaires are completed five times over the course of the study Patients are followed at 3 months
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000067981 | REGISTRY | None | None |
| NCI-G00-1802 | Registry Identifier | PDQ Physician Data Query | None |