Clinical trial NCT00859729: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: DNA
Vaccine
Electroporation
xenogenic
PSA
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Cyto Pulse Sciences, Inc.
First posted: 2009-03-11
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
Secondary outcomes:
measure: Assess the safety and functionality of the DERMA VAX™ in vivo electroporation DNA vaccine delivery system.
timeFrame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
measure: Evaluate the PSA-specific immune response induced by the vaccine.
timeFrame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
measure: Identify an anti-tumor effect of the vaccine.
timeFrame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Oncology, University Hospital Uppsala
Study officials:
affiliation: Department of Oncology, University Hospital Uppsala
name: Jeffrey Yachnin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: