A Phase 2 interventional study of pTVG-HP with rhGM-CSF and pTVG-HP with rhGM-CSF in Prostate Cancer, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-21.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 17 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: pTVG-HP with rhGM-CSF
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.
Biological: pTVG-HP with rhGM-CSF
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
Also known as: DNA-based vaccine encoding PAP
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.
Also known as: DNA-based vaccine encoding PAP
Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment.
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.
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
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.
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.
Time frame: Baseline and 1 year.
The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period.
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.
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 Participants Who Are Metastasis-free at One Year.
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.
Time frame: one year from study entry
Subjects were enrolled between 3/16/2009 and 4/24/2012 and were recruited from the UW Carbone Cancer Center Clinics
| Milestone | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 |
|---|---|---|
| Started | 8 | 9 |
| Completed | 8 | 9 |
| Not completed | 0 | 0 |
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.
| participants | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 |
|---|---|---|
| Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment. | 1 | 0 |
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.
| participants | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 |
|---|---|---|
| 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. | 3 | 6 |
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.
| participants | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 |
|---|---|---|
| The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period. | 3 | 4 |
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.
| participants | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 |
|---|---|---|
| The Number of Participants Who Are Metastasis-free at One Year. | 6 | 6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | — | 3/8 (37.5%) | 8/8 (100%) |
| 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | — | 1/9 (11.1%) | 9/9 (100%) |
| Event | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 |
|---|---|---|
| Pulmonary EmboliVascular disorders | 1/8 | 0/9 |
| HydronephrosisRenal and urinary disorders | 1/8 | 0/9 |
| Bone FractureMusculoskeletal and connective tissue disorders | 1/8 | 0/9 |
| Joint range of motion decreased C-spineMusculoskeletal and connective tissue disorders | 1/8 | 0/9 |
| Avascular NecrosisMusculoskeletal and connective tissue disorders | 0/8 | 1/9 |
| Joint range of motion decreasedMusculoskeletal and connective tissue disorders | 0/8 | 1/9 |
| Event | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 |
|---|---|---|
| Injection site reactionGeneral disorders | 8/8 | 8/9 |
| InfectionInfections and infestations | 5/8 | 3/9 |
| MyalgiaMusculoskeletal and connective tissue disorders | 3/8 | 4/9 |
| Pain BoneGeneral disorders | 2/8 | 4/9 |
| FatigueGeneral disorders | 3/8 | 2/9 |
| ChillsGeneral disorders | 3/8 | 0/9 |
| Chest/thorax painGeneral disorders | 3/8 | 0/9 |
| Joint painMusculoskeletal and connective tissue disorders | 3/8 | 3/9 |
| Back painGeneral disorders | 1/8 | 3/9 |
| RashSkin and subcutaneous tissue disorders | 2/8 | 2/9 |
| Age, Customized(participants) | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | Total |
|---|---|---|---|
| 40-49 years | 1 | 0 | 1 |
| 60-69 years | 1 | 6 | 7 |
| 70-79 years | 1 | 3 | 4 |
| 80-89 years | 5 | 0 | 5 |
| Sex: Female, Male(Participants) | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 8 | 9 | 17 |
| Race/Ethnicity, Customized(participants) | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | Total |
|---|---|---|---|
| White | 8 | 9 | 17 |
| Region of Enrollment(participants) | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | Total |
|---|---|---|---|
| United States | 8 | 9 | 17 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison