Prostate CancerPhase 1/2NCT00859729

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

A Phase 1/2 study testing pVAXrcPSAv53l (DNA encoding rhesus PSA) and DERMA VAX™ intradermal DNA delivery system in people with Prostate Cancer, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: pVAXrcPSAv53l (DNA encoding rhesus PSA) and DERMA VAX™ intradermal DNA delivery system
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteSweden
Study dates: Dec 2008to Nov 2011
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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).

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Department of Oncology, University Hospital Uppsala
Uppsala, 751 85

Other trials in Sweden

About this study

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

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.

Conditions: Prostate Cancer
Being tested: pVAXrcPSAv53l (DNA encoding rhesus PSA), DERMA VAX™ intradermal DNA delivery system
Keywords: DNA, Vaccine, Electroporation, xenogenic, PSA
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pVAXrcPSAv53l (DNA encoding rhesus PSA)Biological
Also called rhPSA
5 doses, 4 weeks apart
DERMA VAX™ intradermal DNA delivery systemDevice
Also called Derma Vax
in vivo electroporation is applied after each DNA injection

Study groups in NCT00859729
Study group	Role	What they receive
Cohort I	Experimental	50 µg DNA/dose, 3 patients Receives: Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA); Device: DERMA VAX™ intradermal DNA delivery system
Cohort II	Experimental	150 µg DNA/dose, 3 patients Receives: Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA); Device: DERMA VAX™ intradermal DNA delivery system
Cohort III	Experimental	400 µg DNA/dose, 3 patients Receives: Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA); Device: DERMA VAX™ intradermal DNA delivery system
Cohort IV	Experimental	1000 µg DNA/dose, 3 patients Receives: Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA); Device: DERMA VAX™ intradermal DNA delivery system
Cohort V	Experimental	Optimal dose to be determined, 6 patients Receives: Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA); Device: DERMA VAX™ intradermal DNA delivery system

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Nov 2011

First posted11 Mar 2009 (estimated)
Study startDec 2008
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Uppsala UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00859729
Sponsor's protocol ID: pVAX/rhPSA -EP 2006
Other IDs: EudraCT # 2006-001128-38
Status last verified: Mar 2014
First submitted: 10 Mar 2009
Last updated: 17 Mar 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00859729
Acronym / sponsor ID: pVAX/rhPSA -EP 2006
Conditions: Prostate Cancer
Keywords: DNA, Vaccine, Electroporation, xenogenic, PSA
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Uppsala UniversityUniversity, hospital or other
Collaborators: Karolinska Institutet, Cyto Pulse Sciences, Inc.
Study start: Dec 2008
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 11 Mar 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Cohort I	Experimental	Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA), Device: DERMA VAX™ intradermal DNA delivery system50 µg DNA/dose, 3 patients
Cohort II	Experimental	Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA), Device: DERMA VAX™ intradermal DNA delivery system150 µg DNA/dose, 3 patients
Cohort III	Experimental	Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA), Device: DERMA VAX™ intradermal DNA delivery system400 µg DNA/dose, 3 patients
Cohort IV	Experimental	Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA), Device: DERMA VAX™ intradermal DNA delivery system1000 µg DNA/dose, 3 patients
Cohort V	Experimental	Biological: pVAXrcPSAv53l (DNA encoding rhesus PSA), Device: DERMA VAX™ intradermal DNA delivery systemOptimal dose to be determined, 6 patients

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pVAXrcPSAv53l (DNA encoding rhesus PSA)Also: rhPSA5 doses, 4 weeks apart	Biological	Cohort I, Cohort II, Cohort III, Cohort IV, Cohort V
DERMA VAX™ intradermal DNA delivery systemAlso: Derma Vaxin vivo electroporation is applied after each DNA injection	Device	Cohort I, Cohort II, Cohort III, Cohort IV, Cohort V

Primary outcome

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

3 secondary outcomes

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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey Yachnin, MD, PhD principal investigator

Department of Oncology, University Hospital Uppsala

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing pVAXrcPSAv53l (DNA encoding rhesus PSA) and DERMA VAX™ intradermal DNA delivery system in people with Prostate Cancer, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: From start of treatment to 30 days (safety) or up to 12 months (immunological & clinical) post last vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00859729.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.