Clinical Trial: A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSF

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD), With or Without Granulocyte Macrophage Colony-Stimulating Factor Adjuvant, in P

Brief Summary: The purpose of this study is to determine if a vaccine called pTVG-AR can enhance patients' immune response against prostate cancer.

Detailed Summary:
Sponsor: University of Wisconsin, Madison

Current Primary Outcome:

  • Number and severity of adverse events following serial intradermal vaccinations of a DNA vaccine encoding AR LBD, with or without GM-CSF as an adjuvant, in patients with metastatic prostate cancer [ Time Frame: From first immunization to Week 72 ]
  • Immune Response Rate [ Time Frame: From first immunization to Week 72 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Median Progression-Free Survival [ Time Frame: From first immunization to Week 72 ]
    Median time to PSA progression will be determined as a function of the date the patient started on androgen deprivation and as a function of treatment start date (week 0). Development of new metastases or discontinuation of study to begin other therapy, while not expected to precede a PSA progression endpoint, would also constitute a progression endpoint.
  • 18-Month Progression-Free Survival [ Time Frame: 18 months ]
  • The proportion of patients with a T-cell immune response. [ Time Frame: From first immunization to Week 72 ]
    Generation of AR LBD-specific peptide-specific CD8+ T cells as defined by ELISPOT and tetramer staining
  • The number of patients that generate antigen specific tolerance [ Time Frame: From first immunization to Week 72 ]
    Antigen-specific tolerance generation following multiple immunizations
  • Association between pre-existing immune responses to the AR LBD and development of subsequent effector and memory T-cell immune response [ Time Frame: From first immunization to Week 72 ]
  • Association between development of antigen-specific T cells and 18-month progression-free survival [ Time Frame: From first immunization to Week 72 ]


Original Secondary Outcome:

  • Median Progression-Free Survival [ Time Frame: From first immunization to Week 72 ]
  • 18-Month Progression-Free Survival [ Time Frame: 18 months ]
  • The proportion of patients with a T-cell immune response. [ Time Frame: From first immunization to Week 72 ]
    Generation of AR LBD-specific peptide-specific CD8+ T cells as defined by ELISPOT and tetramer staining
  • The number of patients that generate antigen specific tolerance [ Time Frame: From first immunization to Week 72 ]
    Antigen-specific tolerance generation following multiple immunizations
  • Association between pre-existing immune responses to the AR LBD and development of subsequent effector and memory T-cell immune response [ Time Frame: From first immunization to Week 72 ]
  • Association between development of antigen-specific T cells and 18-month progression-free survival [ Time Frame: From first immunization to Week 72 ]


Information By: University of Wisconsin, Madison

Dates:
Date Received: March 27, 2015
Date Started: July 2015
Date Completion: December 2022
Last Updated: May 19, 2017
Last Verified: May 2017