Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer
Summary
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.
Timeline
- Start
- 2009-08
- Primary completion
- 2011-05
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | autologous dendritic cells | Cell therapy | 2.5e+07 cells | Other |
| Subject | autologous dendritic cells | Cell therapy | 7.5e+07 cells | Other |
| Subject | autologous dendritic cells | Cell therapy | 1e+08 cells | Other |
| Background | Cyclophosphamide | Other / unclassified | 25 mg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |