Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01706458|
Recruitment Status : Active, not recruiting
First Posted : October 15, 2012
Results First Posted : July 17, 2018
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: sipuleucel-T Biological: DNA Vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer|
|Actual Study Start Date :||May 20, 2013|
|Actual Primary Completion Date :||June 12, 2017|
|Estimated Study Completion Date :||June 12, 2021|
Active Comparator: sipuleucel-T
Patients receive sipuleucel-T IV on weeks 0, 2, and 4.
Other Name: Provenge
Experimental: sipuleucel-T with DNA Vaccine
Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.
Other Name: Provenge
Biological: DNA Vaccine
Other Name: pTVG-HP with rhGM-CSF
- Number of Participants With Immune Response Following Treatment [ Time Frame: 12 months ]The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen.
- Progression-free Survival [ Time Frame: 12 months ]Percentage of patients without radiographic progression at 12 months.
- Time to Radiographic Disease Progression [ Time Frame: 12 months ]Time to radiographic progression using staging obtained at month 3 as baseline for evaluation.
- Measure Prostate-specific Antigen (PSA) Doubling Time [ Time Frame: 12 months ]PSA doubling times were calculated from PSA values obtained up to 6 months from day 1 of study treatment. An increase in the PSA doubling time to at least double the baseline value will be defined as a PSA doubling time "response".
- Overall Survival [ Time Frame: 5 years ]Overall survival is defined as the time interval from randomization to death from any cause or to the last follow-up in censored patients.
- Number of Circulating Tumor Cells [ Time Frame: 6 months ]
- PAP-specific Antibody and T-cell Immune Responses Following Treatment With Sipuleucel-T and DNA Vaccine [ Time Frame: 12 months ]A response resulting from immunization was defined as a PAP-specific response detectable more than once post-treatment that was both significant (compared to media only control), at least 3-fold higher than the pre-treatment value, and with a frequency> 1:100,000 PBMC. An antibody response was defined as any increase in titer over baseline.
- Logistic Regression Analysis Will be Conducted to Evaluate Whether PAP-specific Immune Response is Associated With Prolonged (1-year) Progression-free Survival. [ Time Frame: 12 months ]Not performed because no progression free survival at one year.
- Logistic Regression Analysis Will be Conducted to Evaluate Whether Baseline Immune Responses Predict for Immune Responses Elicited/Augmented Following Treatment With Sipuleucel-T +/- DNA Vaccine. [ Time Frame: 12 months ]Not performed because no progression free survival at one year.
- The Detection of Antigen Spread to Other Prostate Associated Antigens, and the Identification of Specific Antigens Recognized, Will be Analyzed Descriptively. [ Time Frame: 12 months ]Not performed because no progression free survival at one year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706458
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Douglas McNeel, M.D., PhD||University of Wisconsin, Madison|