Trial Outcomes & Findings for Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer (NCT NCT00849121)
NCT ID: NCT00849121
Last Updated: 2019-11-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
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
Results posted on
2019-11-21
Participant Flow
Subjects were enrolled between 3/16/2009 and 4/24/2012 and were recruited from the UW Carbone Cancer Center Clinics
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12
n=8 Participants
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
|
2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12
n=9 Participants
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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-49 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 yearsThe 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.
Outcome measures
| Measure |
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12
n=8 Participants
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
|
2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12
n=9 Participants
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.
|
|---|---|---|
|
Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment.
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline and 1 year.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.
Outcome measures
| Measure |
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12
n=8 Participants
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
|
2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12
n=8 Participants
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.
|
|---|---|---|
|
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 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 yearsThe 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.
Outcome measures
| Measure |
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12
n=8 Participants
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
|
2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12
n=9 Participants
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.
|
|---|---|---|
|
The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period.
|
3 participants
|
4 participants
|
SECONDARY outcome
Timeframe: one year from study entryThe 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.
Outcome measures
| Measure |
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12
n=8 Participants
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
|
2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12
n=9 Participants
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.
|
|---|---|---|
|
The Number of Participants Who Are Metastasis-free at One Year.
|
6 participants
|
6 participants
|
Adverse Events
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12
n=8 participants at risk
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
|
2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12
n=9 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Pulmonary Emboli
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Renal and urinary disorders
Hydronephrosis
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Bone Fracture
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Avascular Necrosis
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased C-spine
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12
n=8 participants at risk
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
|
2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12
n=9 participants at risk
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.
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
12.5%
1/8 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
12.5%
1/8 • Number of events 2
|
0.00%
0/9
|
|
General disorders
Fatigue
|
37.5%
3/8 • Number of events 3
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Chills
|
37.5%
3/8 • Number of events 4
|
0.00%
0/9
|
|
General disorders
Fever without neutropenia
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Injection site reaction
|
100.0%
8/8 • Number of events 47
|
88.9%
8/9 • Number of events 89
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
2/8 • Number of events 2
|
22.2%
2/9
|
|
Endocrine disorders
Hot flashes
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Heart burn
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Number of events 4
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Back pain
|
12.5%
1/8 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
|
General disorders
Headache
|
25.0%
2/8 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Chest/thorax pain
|
37.5%
3/8 • Number of events 5
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
37.5%
3/8 • Number of events 5
|
33.3%
3/9 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
37.5%
3/8 • Number of events 3
|
44.4%
4/9 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Flu-like symptoms
|
0.00%
0/8
|
11.1%
1/9 • Number of events 2
|
|
Infections and infestations
Infection
|
62.5%
5/8 • Number of events 5
|
33.3%
3/9 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • Number of events 2
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Pain neck
|
25.0%
2/8 • Number of events 2
|
0.00%
0/9
|
|
General disorders
Edema
|
25.0%
2/8 • Number of events 2
|
0.00%
0/9
|
|
Investigations
Creatinine
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Sensory
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Cardiac disorders
Bradcardia
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
12.5%
1/8 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
General disorders
Pain Bone
|
25.0%
2/8 • Number of events 6
|
44.4%
4/9 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal bloating
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
General disorders
Breast tenderness
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
|
Eye disorders
Vision change
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Pain--other
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Pain--abdomen
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
|
Renal and urinary disorders
Urinary--other
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
Additional Information
Dr. Douglas McNeel
University of Wisconsin Carbone Cancer Center
Phone: 608-265-8131
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place