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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
University of Wisconsin
Madison, Wisconsin, United States
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)
Time frame: During study treatment and for 15 year follow-up
To determine whether PAP-specific IFNγ-secreting CD8+ T cells can be generated in patients with stage D0 prostate cancer by means of immunization with a plasmid DNA vaccine encoding PAP.
Time frame: 12 months
Efficacy: Immune Response and PSA response
Time frame: During treatment and one year follow-up
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