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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859729
• Other study ID #: pVAX/rhPSA -EP 2006
• Secondary ID: EudraCT # 2006-0
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 10, 2009
• Last updated: March 14, 2014
• Start date: December 2008
• Est. completion date: November 2011

Study information

• Verified date: March 2014
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart

Device:
• DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection

Locations

Country	Name	City	State
Sweden	Department of Oncology, University Hospital Uppsala	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Cyto Pulse Sciences, Inc., Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes