- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00849121
Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
A Pilot Randomized Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
The investigators are trying to find new methods to treat prostate cancer. The approach 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.
The vaccine, called pTVG-HP, is a piece of DNA genetic material that contains genetic code for a protein that is made by the prostate gland, called prostatic acid phosphatase (PAP). The vaccine will be given together with a substance called an adjuvant. Adjuvants are typically given with vaccines and can improve the effect of the vaccine. The adjuvant that will be used in this study is called granulocyte-macrophage colony-stimulating factor (GM-CSF).
The main purpose of this study is to find out whether the vaccine generates long-lived immune responses, and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses. The investigators also want to see if the vaccine stimulates any immune reaction against cancer cells.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Prostate Cancer
- Castrate Resistant Disease with rising PSA despite continuous treatment with orchiectomy or a LHRH agonist
- Rising PSA after treatment and withdrawal of anti-androgen
- Serum Testosterone <50ng/mL
- Normal organ function per laboratory tests
Exclusion Criteria:
- No evidence of immunosuppression or on treatment with immunosuppressive agents
- Cannot have discontinued LHRH agonist treatment (if not previously treated by orchiectomy) within 6 months prior to study entry
- Must not be concurrently taking other medications or supplements with known hormonal effects (other than the LHRH agonist noted above).
- Cannot have any evidence for metastatic disease on bone or CT scan
- Unable or unwilling to undergo two leukapheresis procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.
|
pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d.
biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d.
every 3 months until radiographic disease progression
Other Names:
pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d.
biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response.
Other Names:
|
EXPERIMENTAL: 2
Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.
|
pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d.
biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d.
every 3 months until radiographic disease progression
Other Names:
pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d.
biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment.
Time Frame: From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 years
|
The number and severity of toxicity incidents occurring between the pre-treatment and the final off-study evaluation will be collected and assigned an attribution.
The toxicities observed will be summarized in terms of types and severities by the NCI Common Terminology Criteria version 3 for each study arm.
The number of subjects experiencing grade 2 or higher autoimmune events or grade 3 or higher toxicities felt to be at least possibly related to pTVG-HP with GM-CSF study treatment will be compared between the two arms.
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From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 years
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Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline.
Time Frame: Baseline and 1 year.
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The number of patients with a T-cell immune response will be determined for each study arm.
An immune response will be defined as a PAP-specific T-cell frequency or proliferation index at 1 year that is at least 3-fold higher than the baseline T-cell frequency or proliferation index.
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Baseline and 1 year.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period.
Time Frame: Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years
|
The number of subjects who experience at least a two-fold increase in the PSA doubling time will be documented for each study arm.
The PSA doubling time will be calculated using all PSA values obtained starting on Treatment Day 0 and continuing to end of treatment period and compared to the PSA doubling time collected at study entry prior to beginning study treatment.
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Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years
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The Number of Participants Who Are Metastasis-free at One Year.
Time Frame: one year from study entry
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The number of subjects who are metastatic-free at one year after starting study treatment will be tabulated for each arm.
CT Scans and Bone Scans will be obtained at one year to determine whether metastatic disease is present.
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one year from study entry
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CO08802
- A534260 (Other Identifier: UW Madison)
- SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison)
- H-2008-0102 (OTHER: Institutional Review Board)
- NCI-2011-00859 (REGISTRY: NCI Trial ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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The Affiliated Hospital of the Chinese Academy...Unknown