Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004211
Status:
COMPLETED
Last Update Posted:
2013-03-21
First Post:
2000-01-21
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With RNA Encoding Prostate Specific Antigen PSA
Status:
COMPLETED
Status Verified Date:
2005-01
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 Vaccines may make the body build an immune response to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer
Detailed Description:
OBJECTIVES I Determine the safety and feasibility of prostate specific antigen PSA RNA pulsed autologous dendritic cells in patients with metastatic prostate cancer II Evaluate the presence and magnitude of cellular immune responses against PSA as a surrogate target for immune activation in this patient population III Assess the presence frequency and activation status of peripheral cytotoxic T lymphocytes prior to and following immunotherapy with this regimen in these patients IV Evaluate humoral immune responses as evidenced on circulating peripheral PSA specific antibodies in this patient population V Evaluate delayed type hypersensitivity reactions to irradiated PSA RNA transfected dendritic cells and other standard recall antigens prior to and following immunotherapy in these patients VI Evaluate eventual clinical responses as evidenced on clinical and biochemical PSA response criteria
OUTLINE This is a dose escalation study Patients receive prostate specific antigen PSA RNA pulsed autologous dendritic cells IV over 2 minutes followed by PSA RNA dendritic cells intradermally on weeks 0 2 and 4 for a total of 3 treatments Cohorts of 3-6 patients receive escalating doses of PSA RNA pulsed autologous dendritic cells 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 Patients are followed weekly for 3 months then every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study within 24 months
OUTLINE This is a dose escalation study Patients receive prostate specific antigen PSA RNA pulsed autologous dendritic cells IV over 2 minutes followed by PSA RNA dendritic cells intradermally on weeks 0 2 and 4 for a total of 3 treatments Cohorts of 3-6 patients receive escalating doses of PSA RNA pulsed autologous dendritic cells 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 Patients are followed weekly for 3 months then every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study within 24 months
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 |
|---|---|---|---|
| CDR0000067460 | OTHER | NCI | None |
| DUMC-000408-00-3R1 | None | None | None |
| DUMC-0446-99-3 | None | None | None |
| DUMC-DORIS-99031 | None | None | None |
| NCI-G99-1655 | None | None | None |