Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Uppsala University Karolinska Institutet Cyto Pulse Sciences, Inc. |
---|---|
Information provided by: | Uppsala University |
ClinicalTrials.gov Identifier: | NCT00859729 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA) Device: DERMA VAX™ intradermal DNA delivery system |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | DNA Vaccine Coding for the Rhesus Prostate Specific Antigen (rhPSA) and Electroporation in Patients With Relapsed Prostate Cancer. A Phase I/II Study |
Estimated Enrollment: | 18 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort I: Experimental
50 µg DNA/dose, 3 patients
|
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
|
Cohort II: Experimental
150 µg DNA/dose, 3 patients
|
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
|
Cohort III: Experimental
400 µg DNA/dose, 3 patients
|
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
|
Cohort IV: Experimental
1000 µg DNA/dose, 3 patients
|
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
|
Cohort V: Experimental
Optimal dose to be determined, 3 patients
|
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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function:
Exclusion Criteria:
Contact: Jeffrey Yachnin, MD, PhD | jeffrey.yachnin@akademiska.se |
Sweden | |
Department of Oncology, University Hospital Uppsala | Recruiting |
Uppsala, Sweden, 751 85 | |
Principal Investigator: Jeffrey Yachnin, MD, PhD |
Principal Investigator: | Jeffrey Yachnin, MD, PhD | Department of Oncology, University Hospital Uppsala |
Responsible Party: | Uppsala University Hospital ( Jeffrey Yachnin, MD, PhD ) |
Study ID Numbers: | pVAX/rhPSA -EP 2006, EudraCT # 2006-001128-38 |
Study First Received: | March 10, 2009 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00859729 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
DNA Vaccine Electroporation xenogenic PSA |
Signs and Symptoms Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |