Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289341
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2006-02-07
Brief Title:
Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients Own Immune Cells
Sponsor:
Rockefeller University
Organization:
Rockefeller University
Study Overview
Official Title:
A Phase III Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells DCLNCaP Administered Subcutaneously to Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-01
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:
The purpose of this study is to assess the safety and activity of a type of vaccine as immune therapy for prostate cancer This vaccine will be made for each participants own immune cells called dendritic cells obtained by blood donation Dendritic cells are immune cells whose role is to identify foreign antigens bacteria viruses or tumor cells for example in the body and to activate other cells of the immune system to mount an attack on that foreign antigen Each participant will be randomized into either Arm 1 experimental treatment only or Arm 2 placebo first then the experimental treatment Participants will be given the vaccine and three boosters as an injection After the placebo phase each participant in Arm 2 will crossover to the treatment phase so that all participants will eventually receive the experimental treatment
Detailed Description:
This is a Phase III dendritic cell vaccine study for patients with prostate cancer Our laboratory has demonstrated that effective tumor immunity in humans is associated with and likely mediated at least in part by tumor antigen-specific killer T cells Albert et al 1998a Darnell 1999 Darnell and Posner 2003 Moreover we have demonstrated that apoptotic material derived from dying tumor cells are a potent means of delivering antigen to DCs and subsequently triggering tumor antigen-specific T cell responses ex vivo Albert et al 1998a Albert et al 1998c In this study patients with 3 consecutive rises in PSA measured at least 2 week apart after definite local therapy prostatectomy or radiation will be recruited Peripheral blood monocytes will be collected by leukapheresis and dendritic cells will be generated in the Cleanroom in the Laboratory of Molecular Neuro-Oncology These dendritic cells will be pulsed with apoptotic prostate cancer cells from a cell line LNCaP harvested tested for certain release criteria and then injected as vaccine When patients are found to be eligible for the study they will be randomized into either the experimental group or the placebo group for the purposes of comparing adverse events between groups only Vaccine plus 3 boosters or placebo will be given each two weeks apart After the third booster patients will be unblinded Those receiving the vaccine will when enter the follow up phase which includes a post treatment leukapheresis Those in the placebo group will cross over and receive the vaccine and boosters The primary outcomes to be evaluated are toxicity and activity Patients will be evaluated for both local and systemic toxicity For activity we measure both immunological and clinical responses to the vaccine comparing measures taken before and after vaccination combining patients in both arms
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