PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment
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ClinicalTrials.gov Identifier: NCT00694551 |
Recruitment Status :
Completed
First Posted : June 10, 2008
Results First Posted : February 19, 2014
Last Update Posted : October 4, 2019
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Tracking Information | ||||
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First Submitted Date ICMJE | June 4, 2008 | |||
First Posted Date ICMJE | June 10, 2008 | |||
Results First Submitted Date ICMJE | January 6, 2014 | |||
Results First Posted Date ICMJE | February 19, 2014 | |||
Last Update Posted Date | October 4, 2019 | |||
Actual Study Start Date ICMJE | December 2, 2008 | |||
Actual Primary Completion Date | February 28, 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Occurrence of Related Adverse Events - Grade 3 or Higher [ Time Frame: Up to 48 months ] Number of participants with related Grade 3 or higher adverse events. Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.
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Original Primary Outcome Measures ICMJE |
Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant. [ Time Frame: Approximately 24 months ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Assess the impact of the vaccine on the pattern of PSA change in patients with castrate testosterone level and in patients with non-suppressed testosterone level not on hormone therapy. [ Time Frame: Approximately 24 months ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment | |||
Official Title ICMJE | Pilot Immunotherapy Study of Combination PSMA and TARP Peptide With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment | |||
Brief Summary | Pilot Immunotherapy Study of Combination Prostate Specific Membrane Antigen (PSMA) and T-cell receptor γ alternate reading frame protein (TARP) Peptide With Poly IC-LC Adjuvant in Human Leukocyte Antigens (HLA)-A2 (+) Patients With Elevated prostatic specific antigen (PSA) After Initial Definitive Treatment The purpose of the study is to see if the PSMA/TARP proteins in the vaccine, along with the Hiltonol, can arouse and train the immune system to kill the prostate cancer cells. Prostate cancer is the most common cancer and is the second leading cause of cancer deaths in U.S. males. It is curable when it is confined to the prostate (kept from spreading) using surgery or radiation treatments. In some patients the cancer can come back after these treatments. Treatment options for prostate cancer that comes back include procedures or medications which may have significant risks and side effects. Another plan is being looked at that uses the body's immune system to attack prostate cancer cells. A vaccine has been developed that has proteins found in prostate cancer cells. One of the proteins is called PSMA and the other is called TARP. In addition to these proteins, another substance called Poly IC-LC (Hiltonol) will be added to the vaccine to boost its ability to start the immune system. |
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Detailed Description | Detailed Objectives:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
29 | |||
Original Estimated Enrollment ICMJE |
75 | |||
Actual Study Completion Date ICMJE | December 6, 2018 | |||
Actual Primary Completion Date | February 28, 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00694551 | |||
Other Study ID Numbers ICMJE | MCC-15262 106346 ( Other Identifier: USF IRB ) 20-14555-05-01 ( Other Grant/Funding Number: SPORE in prostate cancer - Pro ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | H. Lee Moffitt Cancer Center and Research Institute | |||
Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | |||
Collaborators ICMJE | National Institutes of Health (NIH) | |||
Investigators ICMJE |
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PRS Account | H. Lee Moffitt Cancer Center and Research Institute | |||
Verification Date | October 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |