Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer (CRITICAL)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Toxicity based on CTCAE v4.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
- Time to objective progression [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy
Intratumoral injection of VDC2008 post-cryotherapy.
Dosage will depend on cohort: 2.5 x 10^7, 7.5 x 10^7 or 1.0 x 10^8
Other Name: Autologous dendritic cells
|United States, California|
|Community Memorial Hospital|
|Ventura, California, United States, 93003|
|Principal Investigator:||Duke K Bahn, M.D.||Prostate Institue of America|