Ignite Creation Date:
2024-05-05 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00694551
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2008-06-04
Brief Title:
PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 Patients With Elevated PSA After Initial Definitive Treatment
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PSMATARP 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 US 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 bodys 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
The purpose of the study is to see if the PSMATARP 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 US 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 bodys 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
Detailed Description:
Detailed Objectives
1 Estimate the frequency of immunological efficacy of the vaccine by comparison of the in vitro enzyme-linked immunosorbent spot ELISpot test results for each antigen PSMA TARP from peripheral blood specimens collected during the periods of time defined as before during and after vaccination
2 Study the safety and toxicity of varying doses of polypeptide vaccines PSMA27-35-PSMA687-701 VLAGGFFLLYRHVIYAPSSHNKYA and TARP13-35 LQLLKQSSRRLEHTFMFLRNFSL administered with a fixed dose of Poly IC-LC 2 mg totaltreatment as adjuvant
3 Describe the impact of the vaccine on the pattern of PSA change in 2 subsets of patients with castrate testosterone with non-suppressed testosterone levelnot on hormone therapy
4 Identify if there is a basis for selection of a dose of the PSMA and the TARP polypeptide vaccines for future phase II development of this vaccination strategy considering the dose range tested
1 Estimate the frequency of immunological efficacy of the vaccine by comparison of the in vitro enzyme-linked immunosorbent spot ELISpot test results for each antigen PSMA TARP from peripheral blood specimens collected during the periods of time defined as before during and after vaccination
2 Study the safety and toxicity of varying doses of polypeptide vaccines PSMA27-35-PSMA687-701 VLAGGFFLLYRHVIYAPSSHNKYA and TARP13-35 LQLLKQSSRRLEHTFMFLRNFSL administered with a fixed dose of Poly IC-LC 2 mg totaltreatment as adjuvant
3 Describe the impact of the vaccine on the pattern of PSA change in 2 subsets of patients with castrate testosterone with non-suppressed testosterone levelnot on hormone therapy
4 Identify if there is a basis for selection of a dose of the PSMA and the TARP polypeptide vaccines for future phase II development of this vaccination strategy considering the dose range tested
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 106346 | OTHER | None | None |
| 20-14555-05-01 | OTHER_GRANT | SPORE in prostate cancer - Pro | None |