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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA); Device: DERMA VAX™ intradermal DNA delivery system

• Registration Number: NCT00859729
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-14
• Last Update Posted: 2014-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort I	pVAXrcPSAv53l (DNA encoding rhesus PSA)	50 µg DNA/dose, 3 patients
Cohort I	DERMA VAX™ intradermal DNA delivery system	50 µg DNA/dose, 3 patients
Cohort II	pVAXrcPSAv53l (DNA encoding rhesus PSA)	150 µg DNA/dose, 3 patients
Cohort II	DERMA VAX™ intradermal DNA delivery system	150 µg DNA/dose, 3 patients
Cohort III	pVAXrcPSAv53l (DNA encoding rhesus PSA)	400 µg DNA/dose, 3 patients
Cohort III	DERMA VAX™ intradermal DNA delivery system	400 µg DNA/dose, 3 patients
Cohort IV	pVAXrcPSAv53l (DNA encoding rhesus PSA)	1000 µg DNA/dose, 3 patients
Cohort IV	DERMA VAX™ intradermal DNA delivery system	1000 µg DNA/dose, 3 patients
Cohort V	pVAXrcPSAv53l (DNA encoding rhesus PSA)	Optimal dose to be determined, 6 patients
Cohort V	DERMA VAX™ intradermal DNA delivery system	Optimal dose to be determined, 6 patients

Primary Outcome Measures

Name	Time	Method
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.	From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination

Secondary Outcome Measures

Name	Time	Method
Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system.	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.	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.	From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination

Trial Locations

Locations (1)

Department of Oncology, University Hospital Uppsala; 🇸🇪 Uppsala, Sweden