Prostate CancerPhase 1NCT00582140
Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer
A Phase 1 study testing pTVG-HP with rhGM-CSF in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The investigators are trying to find new methods to treat prostate cancer. The approach they investigators are taking is to try to enhance patients own immune response against the cancer. In this study the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- pTVG-HP with rhGM-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Aug 2008
- Phase
- Phase 1
- 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
- Must have histologic diagnosis of adenocarcinoma of the prostate
- Must have completed local therapy by surgery and/or ablative radiation therapy at least 2 months prior to entry.
- Must have clinical stage D0 disease defined by the following: In patients treated by surgery, serum PSA values must be > 2 ng/ml by two measurements at least two weeks apart. In patients treated with ablative radiation therapy, three consecutive increases in serum PSA must be documented, with at least a one month interval between values with the finalPSA > 2ng/ml.
- Prior history of a second malignancy is allowed if treated with curative intent disease free for > 5 years.
- Karnofsky performance score of > 70
Who cannot join
- No evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), or radiation therapy to >30% of the bone marrow, within 6 months of the first vaccination.
- Must not be on concurrent androgen ablative (hormonal) therapy, or must have completed this therapy at least one month prior to study entry.
- Must not have demonstrated PSA progression during any prior hormonal therapy or chemotherapy.
- Must not have known evidence of bone metastases or non-regional lymph node involvement (stage D2 disease) as determined by bone scan or CT scan. -Must not have been treated previously with another investigational anti- tumor vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of a DNA-based Vaccine Targeting Prostatic Acid Phosphatase (PAP) in Patients With Stage D0 Prostate Cancer
The investigators are trying to find new methods to treat prostate cancer. The approach they investigators are taking is to try to enhance patients own immune response against the cancer. In this study the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer.
Read the detailed description
The purpose of this research is to determine the safety of serial intradermal vaccinations of a DNA vaccine encoding human PAP, with GM-CSF as a vaccine adjuvant, in subjects with stage D0 prostate cancer. In addition, to determine whether PAP-specific IFNУ-secreting CD8+ T cells can be augmented in subjects with stage D0 prostate cancer by means of immunization with a plasmid DNA vaccine encoding PAP.
This is a phase I design where patients will receive the vaccine pTVG-HP with rhGM-CSF administered i.d. biweekly for 6 total doses. There will be three escalating dose cohorts. The dosing cohort considered to be the maximum tolerated dose level will be expanded up to a total of 16 patients.
- Conditions
- Prostate Cancer
- Being tested
- pTVG-HP with rhGM-CSF
- Keywords
- Prostate, Cancer, Stage D0, Non-Metastatic, Rising PSA
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pTVG-HP with rhGM-CSFBiological
pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
pTVG-HP with rhGM-CSFBiological
pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
pTVG-HP with rhGM-CSFBiological
pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
| Study group | Role | What they receive |
|---|---|---|
| Cohort Level 1 | Experimental | pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses Receives: Biological: pTVG-HP with rhGM-CSF |
| Cohort Level 2 | Experimental | pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses Receives: Biological: pTVG-HP with rhGM-CSF |
| Cohort Level 3 | Experimental | pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses Receives: Biological: pTVG-HP with rhGM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this phase I study is to determine if the vaccination with serial intradermal vaccinations of a DNA-based vaccine targeting PAP, with GM-CSF is safe (the investigators will be evaluating the degree of toxicity seen)
Measured: During study treatment and for 15 year follow-up
To determine whether PAP-specific IFNγ-secreting CD8+ T cells can be generated in patients with stage D0 prostate cancer by means of immunization with a plasmid DNA vaccine encoding PAP.
Measured: 12 months
Secondary outcomes (1)
Efficacy: Immune Response and PSA response
Measured: During treatment and one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startMar 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Douglas McNeel, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582140
- Sponsor's protocol ID
- 2004-0365
- Other IDs
- CO04806, DOD-A-13390, A534260, SMPH/MEDICINE, 2004-0365
- Status last verified
- Jul 2015
- First submitted
- 19 Dec 2007
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnson LE, Olson BM, McNeel DG. Pretreatment antigen-specific immunity and regulation - association with subsequent immune response to anti-tumor DNA vaccination. J Immunother Cancer. 2017 Jul 18;5(1):56. doi: 10.1186/s40425-017-0260-3.
PubMed 28716080Tonelli TP, Eickhoff JC, Johnson LE, Liu G, McNeel DG. Long-term follow up of patients treated with a DNA vaccine (pTVG-hp) for PSA-recurrent prostate cancer. Hum Vaccin Immunother. 2024 Dec 31;20(1):2395680. doi: 10.1080/21645515.2024.2395680. Epub 2024 Aug 29.
PubMed 39208856
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of a DNA-based Vaccine Targeting Prostatic Acid Phosphatase (PAP) in Patients With Stage D0 Prostate Cancer
- ClinicalTrials.gov ID
- NCT00582140
- Acronym / sponsor ID
- 2004-0365
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Stage D0, Non-Metastatic, Rising PSA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Mar 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 28 Dec 2007 (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.
The investigators are trying to find new methods to treat prostate cancer. The approach they investigators are taking is to try to enhance patients own immune response against the cancer. In this study the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer.
Detailed description
The purpose of this research is to determine the safety of serial intradermal vaccinations of a DNA vaccine encoding human PAP, with GM-CSF as a vaccine adjuvant, in subjects with stage D0 prostate cancer. In addition, to determine whether PAP-specific IFNУ-secreting CD8+ T cells can be augmented in subjects with stage D0 prostate cancer by means of immunization with a plasmid DNA vaccine encoding PAP.
This is a phase I design where patients will receive the vaccine pTVG-HP with rhGM-CSF administered i.d. biweekly for 6 total doses. There will be three escalating dose cohorts. The dosing cohort considered to be the maximum tolerated dose level will be expanded up to a total of 16 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort Level 1 | Experimental | Biological: pTVG-HP with rhGM-CSFpTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses |
| Cohort Level 2 | Experimental | Biological: pTVG-HP with rhGM-CSFpTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses |
| Cohort Level 3 | Experimental | Biological: pTVG-HP with rhGM-CSFpTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have histologic diagnosis of adenocarcinoma of the prostate
- Must have completed local therapy by surgery and/or ablative radiation therapy at least 2 months prior to entry.
- Must have clinical stage D0 disease defined by the following: In patients treated by surgery, serum PSA values must be > 2 ng/ml by two measurements at least two weeks apart. In patients treated with ablative radiation therapy, three consecutive increases in serum PSA must be documented, with at least a one month interval between values with the finalPSA > 2ng/ml.
- Prior history of a second malignancy is allowed if treated with curative intent disease free for > 5 years.
- Karnofsky performance score of > 70
Key exclusion criteria (4 listed)
- No evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), or radiation therapy to >30% of the bone marrow, within 6 months of the first vaccination.
- Must not be on concurrent androgen ablative (hormonal) therapy, or must have completed this therapy at least one month prior to study entry.
- Must not have demonstrated PSA progression during any prior hormonal therapy or chemotherapy.
- Must not have known evidence of bone metastases or non-regional lymph node involvement (stage D2 disease) as determined by bone scan or CT scan. -Must not have been treated previously with another investigational anti- tumor vaccine.
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 |
|---|---|---|
| pTVG-HP with rhGM-CSFpTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses | Biological | Cohort Level 1 |
| pTVG-HP with rhGM-CSFpTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses | Biological | Cohort Level 2 |
| pTVG-HP with rhGM-CSFpTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses | Biological | Cohort Level 3 |
Primary outcome
The primary objective of this phase I study is to determine if the vaccination with serial intradermal vaccinations of a DNA-based vaccine targeting PAP, with GM-CSF is safe (the investigators will be evaluating the degree of toxicity seen)
Time frame: During study treatment and for 15 year follow-up
To determine whether PAP-specific IFNγ-secreting CD8+ T cells can be generated in patients with stage D0 prostate cancer by means of immunization with a plasmid DNA vaccine encoding PAP.
Time frame: 12 months
1 secondary outcome
Efficacy: Immune Response and PSA response
Time frame: During treatment and one year follow-up
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 19 Nov 2019.
- Results publication: PubMed 28716080Johnson LE, Olson BM, McNeel DG. Pretreatment antigen-specific immunity and regulation - association with subsequent immune response to anti-tumor DNA vaccination. J Immunother Cancer. 2017 Jul 18;5(1):56. doi: 10.1186/s40425-017-0260-3.
- Derived from this study: PubMed 39208856Tonelli TP, Eickhoff JC, Johnson LE, Liu G, McNeel DG. Long-term follow up of patients treated with a DNA vaccine (pTVG-hp) for PSA-recurrent prostate cancer. Hum Vaccin Immunother. 2024 Dec 31;20(1):2395680. doi: 10.1080/21645515.2024.2395680. Epub 2024 Aug 29.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Douglas McNeel, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pTVG-HP with rhGM-CSF in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.
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 5 inclusion and 4 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 19 Nov 2019. 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 United States. 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 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.
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?
The primary objective of this phase I study is to determine if the vaccination with serial intradermal vaccinations of a DNA-based vaccine targeting PAP, with GM-CSF is safe (the investigators will be evaluating the degree of toxicity seen) (time frame: During study treatment and for 15 year follow-up). The study lists 2 primary outcomes in all. 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 NCT00582140, which also lists 2 linked publications.
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 19 Nov 2019.