Ignite Creation Date:
2024-05-05 @ 9:15 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00849121
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2009-02-19
Brief Title:
Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase PAP in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Pilot Randomized Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase PAP in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2019-03
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:
The investigators are trying to find new methods to treat prostate cancer The approach is to try to enhance patients own immune response against the cancer In this study the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer
The vaccine called pTVG-HP is a piece of DNA genetic material that contains genetic code for a protein that is made by the prostate gland called prostatic acid phosphatase PAP The vaccine will be given together with a substance called an adjuvant Adjuvants are typically given with vaccines and can improve the effect of the vaccine The adjuvant that will be used in this study is called granulocyte-macrophage colony-stimulating factor GM-CSF
The main purpose of this study is to find out whether the vaccine generates long-lived immune responses and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses The investigators also want to see if the vaccine stimulates any immune reaction against cancer cells
The vaccine called pTVG-HP is a piece of DNA genetic material that contains genetic code for a protein that is made by the prostate gland called prostatic acid phosphatase PAP The vaccine will be given together with a substance called an adjuvant Adjuvants are typically given with vaccines and can improve the effect of the vaccine The adjuvant that will be used in this study is called granulocyte-macrophage colony-stimulating factor GM-CSF
The main purpose of this study is to find out whether the vaccine generates long-lived immune responses and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses The investigators also want to see if the vaccine stimulates any immune reaction against cancer cells
Detailed Description:
None
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 |
|---|---|---|---|
| H-2008-0102 | OTHER | None | None |
| NCI-2011-00859 | REGISTRY | None | None |
| A534260 | OTHER | None | None |
| SMPHMEDICINEHEM-ONC | OTHER | UW Madison | None |