Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010127
Status:
TERMINATED
Last Update Posted:
2013-03-21
First Post:
2001-02-02
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 Antigen Encoded in Amplified Autologous Tumor RNA
Status:
TERMINATED
Status Verified Date:
2008-12
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:
RATIONALE Vaccines made from a persons cancer cells may make the body build an immune response to kill prostate tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer
Detailed Description:
OBJECTIVES
Determine the safety and feasibility of autologous dendritic cells transfected with autologous total tumor RNA in patients with metastatic prostate cancer
Determine the presence frequency and activation status of tumor specific and prostate specific antigen PSA specific cellular immune responses in patients treated with this regimen
Determine delayed-type hypersensitivity reactions to PSA protein and other recall antigens in patients before and after being treated with this regimen
Determine clinical responses based on clinical and biochemical PSA response criteria in patients treated with this regimen
Determine a platform for immunological treatment using dendritic-cell based tumor vaccines in these patients
OUTLINE This is a dose escalation study
Tumor tissue and peripheral blood stem cells are collected from patients and cultured in vitro with sargramostim GM-CSF and interleukin-4 for 7 days to produce dendritic cells DC Patients receive autologous DC transfected with autologous prostate carcinoma RNA intradermally once weekly on weeks 0-3 for a total of 4 doses
Cohorts of 3-6 patients receive escalating doses of DC 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
Patients are followed at weeks 6 8 10 and 12 every 3 months for 9 months and then annually for 2 years
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study within 20 months
Determine the safety and feasibility of autologous dendritic cells transfected with autologous total tumor RNA in patients with metastatic prostate cancer
Determine the presence frequency and activation status of tumor specific and prostate specific antigen PSA specific cellular immune responses in patients treated with this regimen
Determine delayed-type hypersensitivity reactions to PSA protein and other recall antigens in patients before and after being treated with this regimen
Determine clinical responses based on clinical and biochemical PSA response criteria in patients treated with this regimen
Determine a platform for immunological treatment using dendritic-cell based tumor vaccines in these patients
OUTLINE This is a dose escalation study
Tumor tissue and peripheral blood stem cells are collected from patients and cultured in vitro with sargramostim GM-CSF and interleukin-4 for 7 days to produce dendritic cells DC Patients receive autologous DC transfected with autologous prostate carcinoma RNA intradermally once weekly on weeks 0-3 for a total of 4 doses
Cohorts of 3-6 patients receive escalating doses of DC 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
Patients are followed at weeks 6 8 10 and 12 every 3 months for 9 months and then annually for 2 years
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study within 20 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 |
|---|---|---|---|
| CDR0000068447 | OTHER | NCI | None |
| DUMC-000759-00-4R1 | None | None | None |
| DUMC-DORIS-99043 | None | None | None |
| NCI-G00-1910 | None | None | None |