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Sponsors and Collaborators: |
University of Wisconsin, Madison Department of Defense |
Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00582140 |
We are trying to find new methods to treat prostate cancer. The approach we are taking is to try to enhance patients own immune response against the cancer. In this study we will be testing the safety of a vaccine that may be able to help the body fight prostate cancer.
Condition | Intervention | Phase |
Prostate Cancer |
Biological: pTVG-HP with rhGM-CSF |
Phase I Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study of a DNA-Based Vaccine Targeting Prostatic Acid Phosphatase (PAP) in Patients With Stage D0 Prostate Cancer |
Enrollment: | 22 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Cohort Level 1: Experimental
pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
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Biological: pTVG-HP with rhGM-CSF
pTVG-HP (dose 1: 100 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
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Cohort Level 2: Experimental
pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
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Biological: pTVG-HP with rhGM-CSF
pTVG-HP (dose 2: 500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
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Cohort Level 3: Experimental
pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
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Biological: pTVG-HP with rhGM-CSF
pTVG-HP (dose 3: 1,500 μg) with rhGM-CSF (200 μg); administered i.d. biweekly for 6 total doses
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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/II 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Wisconsin | |||||
University of Wisconsin | |||||
Madison, Wisconsin, United States, 53792 |
University of Wisconsin, Madison |
Department of Defense |
Principal Investigator: | Douglas McNeel, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin ( Douglas McNeel MD/Principal Investigator ) |
Study ID Numbers: | HSC 2004-0365, CO04806, DOD-A-13390 |
First Received: | December 19, 2007 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00582140 |
Health Authority: | United States: Food and Drug Administration |
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