Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer
| Status: | Archived |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | August 2009 |
| End Date: | December 2011 |
A Phase I/IIa Trial of Combined Cryotherapy and Intra-tumoral Immunotherapy With Autologous Immature Dendritic Cells (VDC2008) in Chemo-naïve Men With Prostatic Adenocarcinoma and Limited Metastases to Lymph Nodes and/or Bone
The purpose of this study is to determine if the intra-tumoral injection of a subject's own
dendritic cells after cryotherapy of the prostate is a safe and effective treatment for
advanced prostate cancer.
In theory, the injected dendritic cells will internalize antigens from the tumor cells which
have been damaged by cryotherapy and activate the subject's immune system against that
specific tumor.
Subjects will also receive a low dose chemotherapy designed to lower the number of
T-regulatory cells which have been shown to lower or stop some immune system responses.
Hypothesis 1: Dendritic cell injection into cryotreated prostate cancer is non-toxic;
Hypothesis 2: Dendritic cell injection into cryotreated prostate cancer is medically
beneficial to the subject.
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