Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer
DNA Vaccine Coding for the Rhesus Prostate Specific Antigen (rhPSA) and Electroporation in Patients With Relapsed Prostate Cancer. A Phase I/II Study
2 other identifiers
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 prostate-cancer
Started Dec 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 10, 2009
CompletedFirst Posted
Study publicly available on registry
March 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedMarch 17, 2014
March 1, 2014
2.9 years
March 10, 2009
March 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (5)
Cohort I
EXPERIMENTAL50 µg DNA/dose, 3 patients
Cohort II
EXPERIMENTAL150 µg DNA/dose, 3 patients
Cohort III
EXPERIMENTAL400 µg DNA/dose, 3 patients
Cohort IV
EXPERIMENTAL1000 µg DNA/dose, 3 patients
Cohort V
EXPERIMENTALOptimal dose to be determined, 6 patients
Interventions
5 doses, 4 weeks apart
in vivo electroporation is applied after each DNA injection
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Karolinska Institutetcollaborator
- Cyto Pulse Sciences, Inc.collaborator
Study Sites (1)
Department of Oncology, University Hospital Uppsala
Uppsala, 751 85, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Yachnin, MD, PhD
Department of Oncology, University Hospital Uppsala
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicple Investigator
Study Record Dates
First Submitted
March 10, 2009
First Posted
March 11, 2009
Study Start
December 1, 2008
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
March 17, 2014
Record last verified: 2014-03