Trials / Completed
CompletedNCT00859729
Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer
DNA Vaccine Coding for the Rhesus Prostate Specific Antigen (rhPSA) and Electroporation in Patients With Relapsed Prostate Cancer. A Phase I/II Study
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Uppsala University · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the feasibility and safety of vaccination with increasing doses of xenogenic DNA administered intradermally in combination with electroporation in patients with relapse of prostate cancer. The DNA encodes prostate specific antigen (PSA) from Rhesus Macaque (Macaca mulatta), a protein that is 89% homologous to human PSA. The study will also assess the safety and functionality of the DERMA VAX™ (Cyto Pulse Sciences) DNA vaccine delivery system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pVAXrcPSAv53l (DNA encoding rhesus PSA) | 5 doses, 4 weeks apart |
| DEVICE | DERMA VAX™ intradermal DNA delivery system | in vivo electroporation is applied after each DNA injection |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2011-11-01
- Completion
- 2011-11-01
- First posted
- 2009-03-11
- Last updated
- 2014-03-17
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT00859729. Inclusion in this directory is not an endorsement.