Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006430
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-11-03
Brief 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
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2002-02
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:
Purpose This protocol proposes a safety and feasibility trial in patients with metastatic prostate cancer stages D1-D3 investigating the induction of antitumor immunity by administration of cultured autologous peripheral blood precursor derived dendritic cells DC transfected with mRNA amplified from autologous prostate tumor tissue The feasibility and dose-limiting toxicity of administering escalating doses of tumor RNA transfected dendritic cells will be defined As a secondary endpoint the ability of tumor RNA transfected dendritic cells to induce tumor-specific immune responses will be evaluated Finally the anti-tumor effect based on PSA biochemical response criteria will be defined
Background Because prostate cancer is incurable when metastatic and conventional therapies do not offer a clear survival benefit new therapeutic strategies are warranted This study is based on the premise that clinically effective cell mediated immune responses against prostate tumors can be elicited by activation of tumor associated antigen specific T cells Work performed by others and our group suggests that PSA a protein expressed in virtually all prostate cancers can serve as a widely expressed candidate antigen for prostate cancer immunotherapy In particular we have shown that cultured dendritic cells transfected with mRNA encoding PSA are remarkably effective in stimulating antigen specific immunity in vitro Therefore we hypothesize that administration of PSA RNA transfected DC will lead to detectable levels of PSA specific CTL in the peripheral blood of patients with PSA expressing metastatic prostate cancer It is hoped that these T cell responses also have clinical antitumor activity
Background Because prostate cancer is incurable when metastatic and conventional therapies do not offer a clear survival benefit new therapeutic strategies are warranted This study is based on the premise that clinically effective cell mediated immune responses against prostate tumors can be elicited by activation of tumor associated antigen specific T cells Work performed by others and our group suggests that PSA a protein expressed in virtually all prostate cancers can serve as a widely expressed candidate antigen for prostate cancer immunotherapy In particular we have shown that cultured dendritic cells transfected with mRNA encoding PSA are remarkably effective in stimulating antigen specific immunity in vitro Therefore we hypothesize that administration of PSA RNA transfected DC will lead to detectable levels of PSA specific CTL in the peripheral blood of patients with PSA expressing metastatic prostate cancer It is hoped that these T cell responses also have clinical antitumor activity
Detailed Description:
Methods Patients will undergo percutaneous needle biopsies from either primary or metastatic sites to obtain tumor tissue Patients in whom sufficient tumor mRNA has been amplified by PCR to transfect the assigned dendritic cell dose will undergo leukapheresis and peripheral blood mononuclear cells will be cultured in vitro for 7 days with GM-CSF and IL-4 to generate precursor derived dendritic cells Dendritic cells will then be cryopreserved for later use On the day the patient returns to receive his infusion weeks 0 2 and 4 the dendritic cells will be thawed reconstituted and transfected with amplified total tumor mRNA Patients will receive a total of 3 treatments consisting of combined IV and ID injections each on study week 0 2 and 4 Repeat leukapheresis will be performed 2 weeks after the last dose to determine immune function PSA levels will be measured prior to the start of treatment and 2 weeks following the last infusion Patients who do not receive therapy due to a failure to produce sufficient RNA or dendritic cells will be replaced in order to assess toxicity
Data Analysis 1 To determine the short and long term toxicities associated with administration of tumor RNA dendritic cells in patients with metastatic prostate cancer 2 To determine feasibility of dendritic cell vaccine generation according to the proportion of patients for whom sufficient cells are generated to provide treatment 3 To determine the cellular immune response to intravenous infusion of tumor RNA dendritic cells 4 To measure the PSA response of patients with metastatic prostate cancer to intravenous infusion of tumor RNA dendritic cells
Data Analysis 1 To determine the short and long term toxicities associated with administration of tumor RNA dendritic cells in patients with metastatic prostate cancer 2 To determine feasibility of dendritic cell vaccine generation according to the proportion of patients for whom sufficient cells are generated to provide treatment 3 To determine the cellular immune response to intravenous infusion of tumor RNA dendritic cells 4 To measure the PSA response of patients with metastatic prostate cancer to intravenous infusion of tumor RNA dendritic cells
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000030 | NIH | None | httpsreporternihgovquickSearchM01RR000030 |