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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00859729
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : March 17, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA) Device: DERMA VAX™ intradermal DNA delivery system Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2008
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cohort I
50 µg DNA/dose, 3 patients
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
Other Name: rhPSA
Device: DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Name: Derma Vax
Experimental: Cohort II
150 µg DNA/dose, 3 patients
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
Other Name: rhPSA
Device: DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Name: Derma Vax
Experimental: Cohort III
400 µg DNA/dose, 3 patients
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
Other Name: rhPSA
Device: DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Name: Derma Vax
Experimental: Cohort IV
1000 µg DNA/dose, 3 patients
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
Other Name: rhPSA
Device: DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Name: Derma Vax
Experimental: Cohort V
Optimal dose to be determined, 6 patients
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
Other Name: rhPSA
Device: DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Name: Derma Vax


Outcome Measures

Primary Outcome Measures :
  1. Assess the feasibility and safety of escalating doses of pVAXrcPSAv53l DNA vaccine, administered intradermally in combination with electroporation in patients with relapse of prostate cancer. [ Time Frame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination ]

Secondary Outcome Measures :
  1. Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system. [ Time Frame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination ]
  2. Evaluate the PSA-specific immune response induced by the vaccine. [ Time Frame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination ]
  3. Identify an anti-tumor effect of the vaccine. [ Time Frame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patients. Age >18 years.
  • HLA-A*0201 positive.
  • Histologically confirmed prostate cancer.
  • Minimum two (2) and maximum four (4) years after treatment with curative or salvage radiotherapy.
  • Serum testosterone within normal range.
  • Increasing PSA from a previous reference value on two (2) consecutive occasions at least one month apart and with a minimum of 2 ng/mL above nadir.
  • PSA doubling time is one (1) year or less.
  • No evidence of metastatic prostate cancer.
  • Karnofsky performance status ≥ 80.
  • Adequate organ function:

    • AST and ALT ≤ 2.0 x upper limit of normal (ULN); total serum bilirubin ≤ 1.5 x ULN
    • Calcium ≤ 2.6 mmol/L, serum creatinine ≤ 1.5 x ULN
    • Hb ≥ 100 g/L; absolute leukocyte count ≥ 3.0 x 109 /L; platelets ≥100 x 109 /L
  • Life expectancy ≥ 12 months.
  • Swedish or English speaking subjects only.
  • Written informed consent (subjects must be capable of providing their own informed consent).

Exclusion Criteria:

  • Previous ablation of testis.
  • Radiologic evidence of metastatic disease.
  • Prior chemotherapy or investigational therapy/agents within 4 weeks.
  • Active bacterial, viral or fungal infection.
  • Carrier of HIV, HBV, or HCV.
  • Immunosuppressed (post splenectomy, post stem cell transplantation) or on immunosuppressive therapy other than inhaled or replacement corticosteroids.
  • Any other major illness or peripheral blood vein status that, in the investigator's judgement, will substantially increase the risk associated with sampling or participation in this study.
  • Subjects with cardiac demand pacemakers.
  • Any reason why, in the opinion of the investigator, the patient should not participate.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859729


Locations
Sweden
Department of Oncology, University Hospital Uppsala
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University
Karolinska Institutet
Cyto Pulse Sciences, Inc.
Investigators
Principal Investigator: Jeffrey Yachnin, MD, PhD Department of Oncology, University Hospital Uppsala
More Information

Responsible Party: Jeffrey Yachnin, Prinicple Investigator, Uppsala University
ClinicalTrials.gov Identifier: NCT00859729     History of Changes
Other Study ID Numbers: pVAX/rhPSA -EP 2006
EudraCT # 2006-001128-38
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014

Keywords provided by Jeffrey Yachnin, Uppsala University:
DNA
Vaccine
Electroporation
xenogenic
PSA

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs