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

March 14, 2014 updated by: Jeffrey Yachnin, Uppsala University

DNA Vaccine Coding for the Rhesus Prostate Specific Antigen (rhPSA) and Electroporation in Patients With Relapsed Prostate Cancer. A Phase I/II Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 85
        • Department of Oncology, University Hospital Uppsala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
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
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
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
From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Karolinska Institutet
Cyto Pulse Sciences, Inc.

Investigators

  • Principal Investigator: Jeffrey Yachnin, MD, PhD, Department of Oncology, University Hospital Uppsala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Estimate)

March 17, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pVAX/rhPSA -EP 2006
  • EudraCT # 2006-001128-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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