Prostate Cancer Clinical Trial
Official title:
Phase I Study of a DNA-based Vaccine Targeting Prostatic Acid Phosphatase (PAP) in Patients With Stage D0 Prostate Cancer
The investigators are trying to find new methods to treat prostate cancer. The approach they investigators are taking 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 purpose of this research is to determine the safety of serial intradermal vaccinations of
a DNA vaccine encoding human PAP, with GM-CSF as a vaccine adjuvant, in subjects with stage
D0 prostate cancer. In addition, to determine whether PAP-specific IFNУ-secreting CD8+ T
cells can be augmented in subjects with stage D0 prostate cancer by means of immunization
with a plasmid DNA vaccine encoding PAP.
This is a phase I design where patients will receive the vaccine pTVG-HP with rhGM-CSF
administered i.d. biweekly for 6 total doses. There will be three escalating dose cohorts.
The dosing cohort considered to be the maximum tolerated dose level will be expanded up to a
total of 16 patients.
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