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Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer

NCT00859729 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-03-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Cyto Pulse Sciences, Inc.

    collaborator INDUSTRY

  • Uppsala University

    lead OTHER

Principal Investigators

  • Jeffrey Yachnin, MD, PhD · Department of Oncology, University Hospital Uppsala

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00859729 on ClinicalTrials.gov