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

This study has been completed.
Sponsor:
Collaborators:
Karolinska Institutet
Cyto Pulse Sciences, Inc.
Information provided by (Responsible Party):
Jeffrey Yachnin, Uppsala University
ClinicalTrials.gov Identifier:
NCT00859729
First received: March 10, 2009
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: December 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 10, 2009
Last Updated: March 14, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by 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

ClinicalTrials.gov processed this record on August 01, 2014