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| ID | Type | Description | Link |
|---|---|---|---|
| H-2008-0102 | Other Identifier | Institutional Review Board | |
| NCI-2011-00859 | Registry Identifier | NCI Trial ID | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
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| 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pTVG-HP with rhGM-CSF | Biological | 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 |
| 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. | 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. | 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. | Baseline and 1 year. |
| 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas McNeel, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39208856 | Derived | Tonelli 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. |
| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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Subjects were enrolled between 3/16/2009 and 4/24/2012 and were recruited from the UW Carbone Cancer Center Clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 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 with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally (i.d.) biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally every 3 months until radiographic disease progression |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| pTVG-HP with rhGM-CSF | Biological | 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. |
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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 |
| 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. | one year from study entry |
| FG001 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 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 with rhGM-CSF: 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 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 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 |
| BG001 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 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 with rhGM-CSF: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 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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| Primary | 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. | Posted | Number | participants | Baseline and 1 year. |
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| Secondary | 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. | Posted | Number | participants | 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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| Secondary | 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. | Posted | Number | participants | one year from study entry |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 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 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 | 3 | 8 | 8 | 8 | ||
| EG001 | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 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 with rhGM-CSF: 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. | 1 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Emboli | Vascular disorders | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
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| Bone Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Avascular Necrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Joint range of motion decreased C-spine | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Systematic Assessment | Left hip |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Chills | General disorders | Non-systematic Assessment |
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| Fever without neutropenia | General disorders | Systematic Assessment |
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| Injection site reaction | General disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hot flashes | Endocrine disorders | Non-systematic Assessment |
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| Heart burn | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Back pain | General disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Chest/thorax pain | General disorders | Non-systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Flu-like symptoms | General disorders | Non-systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pain neck | General disorders | Non-systematic Assessment |
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| Edema | General disorders | Systematic Assessment |
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| Creatinine | Investigations | Systematic Assessment |
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| Sensory | Nervous system disorders | Non-systematic Assessment | Cramps to hands and feet |
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| Bradcardia | Cardiac disorders | Systematic Assessment |
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| Urinary frequency/urgency | Renal and urinary disorders | Non-systematic Assessment |
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| Pain Bone | General disorders | Non-systematic Assessment |
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| Abdominal bloating | Gastrointestinal disorders | Non-systematic Assessment |
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| Breast tenderness | General disorders | Non-systematic Assessment |
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| Vision change | Eye disorders | Non-systematic Assessment | hazy vision |
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| Pain--other | General disorders | Non-systematic Assessment | testicle pain |
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| Pain--abdomen | General disorders | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | Non-systematic Assessment | Burning on urination |
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| Urinary--other | Renal and urinary disorders | Non-systematic Assessment | Slow urine stream/dribbling |
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Of the 17 participants enrolled, 16 received at least 6 initial immunizations with pTVG-HP vaccine and were deemed evaluable to be assessed for outcome measure 3.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Douglas McNeel | University of Wisconsin Carbone Cancer Center | 608-265-8131 | dm3@medicine.wisc.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C082856 | regramostim |
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| Title | Measurements |
|---|---|
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| 70-79 years |
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| 80-89 years |
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| Male |
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| Units | Counts |
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| Participants |
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