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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

pVAXrcPSAv53l (DNA encoding rhesus PSA)

DERMA VAX™ intradermal DNA delivery system

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring DNA, Vaccine, Electroporation, xenogenic, PSA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Department of Oncology, University Hospital Uppsala

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Cohort I

Cohort II

Cohort III

Cohort IV

Cohort V

Arm Description

50 µg DNA/dose, 3 patients

150 µg DNA/dose, 3 patients

400 µg DNA/dose, 3 patients

1000 µg DNA/dose, 3 patients

Optimal dose to be determined, 6 patients

Outcomes

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.

Secondary Outcome Measures

Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system.

Evaluate the PSA-specific immune response induced by the vaccine.

Identify an anti-tumor effect of the vaccine.

Full Information

NCT ID

NCT00859729

First Posted

March 10, 2009

Last Updated

March 14, 2014

Sponsor

Uppsala University

Collaborators

Karolinska Institutet, Cyto Pulse Sciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00859729

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Uppsala University

Collaborators

Karolinska Institutet, Cyto Pulse Sciences, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

DNA, Vaccine, Electroporation, xenogenic, PSA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort I

Arm Type

Experimental

Arm Description

50 µg DNA/dose, 3 patients

Arm Title

Cohort II

Arm Type

Experimental

Arm Description

150 µg DNA/dose, 3 patients

Arm Title

Cohort III

Arm Type

Experimental

Arm Description

400 µg DNA/dose, 3 patients

Arm Title

Cohort IV

Arm Type

Experimental

Arm Description

1000 µg DNA/dose, 3 patients

Arm Title

Cohort V

Arm Type

Experimental

Arm Description

Optimal dose to be determined, 6 patients

Intervention Type

Biological

Intervention Name(s)

pVAXrcPSAv53l (DNA encoding rhesus PSA)

Other Intervention Name(s)

rhPSA

Intervention Description

5 doses, 4 weeks apart

Intervention Type

Device

Intervention Name(s)

DERMA VAX™ intradermal DNA delivery system

Other Intervention Name(s)

Derma Vax

Intervention Description

in vivo electroporation is applied after each DNA injection

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Yachnin, MD, PhD

Organizational Affiliation

Department of Oncology, University Hospital Uppsala

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, University Hospital Uppsala

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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