Phase I Study of a DNA-based Vaccine Targeting Prostatic Acid Phosphatase (PAP) in Patients With Stage D0 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this phase I study is to determine if the vaccination with serial intradermal vaccinations of a DNA-based vaccine targeting PAP, with GM-CSF is safe (the investigators will be evaluating the degree of toxicity seen)
During study treatment and for 15 year follow-up
Douglas McNeel, MD
University of Wisconsin, Madison
United States: Food and Drug Administration
|University of Wisconsin||Madison,, Wisconsin 53792-5666|