Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer
NCT ID: NCT00859729
Last Updated: 2014-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2008-12-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort I
50 µg DNA/dose, 3 patients
pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Cohort II
150 µg DNA/dose, 3 patients
pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Cohort III
400 µg DNA/dose, 3 patients
pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Cohort IV
1000 µg DNA/dose, 3 patients
pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Cohort V
Optimal dose to be determined, 6 patients
pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Interventions
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pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Karolinska Institutet
OTHER
Cyto Pulse Sciences, Inc.
INDUSTRY
Uppsala University
OTHER
Responsible Party
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Jeffrey Yachnin
Prinicple Investigator
Principal Investigators
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Jeffrey Yachnin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Oncology, University Hospital Uppsala
Locations
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Department of Oncology, University Hospital Uppsala
Uppsala, , Sweden
Countries
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Other Identifiers
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EudraCT # 2006-001128-38
Identifier Type: -
Identifier Source: secondary_id
pVAX/rhPSA -EP 2006
Identifier Type: -
Identifier Source: org_study_id
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