A Pilot Study of Vaccination With Epitope-Enhanced TARP Peptide and TARP Peptide-Pulsed Dendritic Cells in the Treatment of Stage D0 Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00972309|
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : January 14, 2020
- PSA (prostate specific antigen) is a protein found on normal and cancerous prostate cells. Levels of this protein are used to identify men who are at risk for prostate cancer and to monitor responses to treatment in men who have been diagnosed with prostate cancer.
- Research has shown that men who continue to have an elevated PSA level following primary treatment for prostate cancer are at increased risk for cancer progression. Studies have shown that the change in PSA levels over time, or PSA doubling time (PSADT), can be accurate in predicting how quickly the cancer is likely to progress. Individuals with a PSADT of less than 3 months are at extremely high risk for disease progression and death from prostate cancer. Individuals with a PSADT of greater than 15 months have a very low risk of death from prostate cancer.
- TARP is a protein that is found in about 95% of prostate cancers and is known to stimulate the immune system. The TARP prostate cancer vaccine is made from pieces of the TARP protein called peptides and includes peptides that have been modified to make them more effective at stimulating immunity. Although these TARP peptides have been shown to stimulate the immune systems of mice, information is needed to determine if they also stimulate the immune system in humans. Since it is unclear what is the best way to give peptide vaccines, the TARP peptides will be given with substances known to stimulate the immune system or in a vaccine made with the patient s own cells.
- To determine the immune system s response to vaccination with TARP peptides.
- To determine the safety and toxicity of TARP peptide vaccination.
- To determine if vaccination with the TARP prostate cancer vaccine can slow down PSADT in men with an intermediate PSADT of 3 to 15 months.
- Males 18 years of age and older who have completed their primary treatment for prostate cancer, have stage D0 disease, are HLA A*0201 positive and who have a PSADT greater than 3 and less than 15 months.
- Patients will be randomized to one of two treatment arms:
- Arm A will receive the TARP vaccine with other substances that stimulate the immune system.
- Arm B will receive the TARP vaccine that includes a patient s own white blood cells.
- First week of study, after screening for eligibility has been completed:
- Day 1: Apheresis procedure to extract white blood cells to test the immune response to the vaccine.
- Day 3: Flu vaccine to allow researchers to determine how well a patient s immune system is working.
- Clinic visits in Weeks 3, 6, 9, 12, and 15 for physical examination, blood samples, and administration of the TARP peptide vaccine.
- Physical examination and blood samples only in Weeks 18 and 36.
- Additional blood samples and apheresis procedures in Weeks 24 and 48.
- A 6th dose of TARP peptide vaccine will be administer to those patients who have a response to vaccination at week 24.
- No follow-up or long-term study is associated with this study.
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms Prostate Specific Antigens||Biological: TARP peptide vaccine Biological: TARP dendritic cell vaccine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Vaccination With Epitope-Enhanced TARP Peptide and TARP Peptide-Pulsed Dendritic Cells in the Treatment of Stage D0 Prostate Cancer|
|Study Start Date :||May 25, 2009|
|Actual Primary Completion Date :||February 4, 2015|
|Actual Study Completion Date :||February 4, 2015|
Biological: TARP peptide vaccine
Will receive an admixture of the wildtype and epitopeenhanced TARP peptides emulsified with Montanide ISA 51 VG and GM-CSF. TARP peptide will be administered subcutaneously at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96
TARP dendritic cells
Biological: TARP dendritic cell vaccine
Will receive peptidepulsed dendritic cells administered intradermally in two vaccination sites. TARP pulsed dendritic cells will be administered at weeks 3, 6, 9, 12 and 15 for a total of five vaccinations with a booster dose of vaccine at Weeks 48 and 96.
- Immunologic response rate to vaccination [ Time Frame: Every 12 weeks through wk 60, additional assessment at wk 18 and wk 96 ]Presence of T-lymphocyte cells in patients' specimen using tetramer staining, IFNELISPOT and 51Cr release CTL assays.
- Determine the safety and toxicity od TARP vaccines [ Time Frame: continuously through 30 days after last vaccination ]The quantity of AEs each subject experiences.
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): NCT00972309
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Hoyoung M Maeng, M.D.||National Cancer Institute (NCI)|