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

Uppsala University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA); Device: DERMA VAX™ intradermal DNA delivery system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00859729

pVAX/rhPSA -EP 2006

EudraCT # 2006-001128-38

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 5 patient groups

Cohort I

Experimental group

Description:

50 µg DNA/dose, 3 patients

Treatment:

Device: DERMA VAX™ intradermal DNA delivery system

Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)

Cohort II

Experimental group

Description:

150 µg DNA/dose, 3 patients

Treatment:

Device: DERMA VAX™ intradermal DNA delivery system

Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)

Cohort III

Experimental group

Description:

400 µg DNA/dose, 3 patients

Treatment:

Device: DERMA VAX™ intradermal DNA delivery system

Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)

Cohort IV

Experimental group

Description:

1000 µg DNA/dose, 3 patients

Treatment:

Device: DERMA VAX™ intradermal DNA delivery system

Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)

Cohort V

Experimental group

Description:

Optimal dose to be determined, 6 patients

Treatment:

Device: DERMA VAX™ intradermal DNA delivery system

Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)