Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Uppsala University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Uppsala University
Collaborators:
Karolinska Institutet
Cyto Pulse Sciences, Inc.
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT00859729
First received: March 10, 2009
Last updated: January 20, 2010
Last verified: January 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA) Device: DERMA VAX™ intradermal DNA delivery system |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Uppsala University:
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. [ Time Frame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 18 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort I
50 µg DNA/dose, 3 patients
|
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
Other Name: rhPSA
Device: DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Name: Derma Vax
|
|
Experimental: Cohort II
150 µg DNA/dose, 3 patients
|
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
Other Name: rhPSA
Device: DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Name: Derma Vax
|
|
Experimental: Cohort III
400 µg DNA/dose, 3 patients
|
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
Other Name: rhPSA
Device: DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Name: Derma Vax
|
|
Experimental: Cohort IV
1000 µg DNA/dose, 3 patients
|
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
Other Name: rhPSA
Device: DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Name: Derma Vax
|
|
Experimental: Cohort V
Optimal dose to be determined, 6 patients
|
Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA)
5 doses, 4 weeks apart
Other Name: rhPSA
Device: DERMA VAX™ intradermal DNA delivery system
in vivo electroporation is applied after each DNA injection
Other Name: Derma Vax
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859729
Contacts
| Contact: Jeffrey Yachnin, MD, PhD | jeffrey.yachnin@akademiska.se |
Locations
| Sweden | |
| Department of Oncology, University Hospital Uppsala | Recruiting |
| Uppsala, Sweden, 751 85 | |
| Principal Investigator: Jeffrey Yachnin, MD, PhD | |
Sponsors and Collaborators
Uppsala University
Karolinska Institutet
Cyto Pulse Sciences, Inc.
Investigators
| Principal Investigator: | Jeffrey Yachnin, MD, PhD | Department of Oncology, University Hospital Uppsala |
More Information
No publications provided
| Responsible Party: | Jeffrey Yachnin, MD, PhD, Uppsala University Hospital |
| ClinicalTrials.gov Identifier: | NCT00859729 History of Changes |
| Other Study ID Numbers: | pVAX/rhPSA -EP 2006, EudraCT # 2006-001128-38 |
| Study First Received: | March 10, 2009 |
| Last Updated: | January 20, 2010 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Uppsala University:
|
DNA Vaccine Electroporation xenogenic PSA |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013