Version 10/7/2015 Randomized Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) versus GM-CSF Adjuvant in Patients with Non-Metastatic Prostate Cancer CO 08801 Investigational Agent: BB IND 12109 - pTVG-HP DNA encoding human prostatic acid phosphatase Study Sponsors: 56 patients – treated at UWCCC and UCSF Department of Defense Prostate Cancer Research Program federal grant 50 patients in biomarker cohort – treated at UWCCC, UCSF and JHU Madison Vaccines Inc. (MVI) corporate sponsor STUDY SITE INFORMATION Study Sites: University of Wisconsin Carbone Cancer Center (UWCCC) 1111 Highland Avenue Madison, WI 53705 University of California San Francisco (UCSF) Johns Hopkins School of Medicine (JHU) Study Principal Investigator: Douglas G. McNeel, M.D., Ph.D. UWCCC 7007 Wisconsin Institutes for Medical Research 1111 Highland Ave. Madison, WI 53705 Tel: (608) 263-4198 Fax: (608) 265-0614
[email protected] UWCCC Local Principal Investigator : Glenn Liu, MD UWCCC 7051 Wisconsin Institutes for Medical Research 1111 Highland Ave. Madison, WI 53705 Tel : (608) 265-8689 Fax : (608) 265-5146
[email protected] Medical Monitor: Mark Albertini, M.D. UWCCC 600 Highland Ave. K6/5 CSC Madison, WI 53792 Tel: (608) 265-8131 Fax: (608) 265-8133
[email protected] Other UWCCC Investigators: Joshua Lang, M.D. – Clinical Investigator Christos Kyriakopolous, M.D. – Clinical Investigator Robert Jeraj, Ph.D. – Medical Physics, Quantitative Total Bone Imaging Scott Perlman, M.D. – Nuclear Medicine UCSF Principal Investigator: Lawrence Fong, M.D. JHU Principal Investigator: Emmanuel Antonarakis, MD Study Coordinator: Mary Jane Staab, R.N. B.S.N. UWCCC 600 Highland Ave.