PAGE 1.0 Goals and Objectives (Scientific Aims) ............................................................................ 11 2.0 Background ....................................................................................................................... 11 2.1 Introduction/Rationale for Development ............................................................. 11 2.2 Overview of Proposed Study ............................................................................... 12 2.3 Preclinical Studies ................................................................................. 12 2.4 Human Studies ..................................................................................................... 12 2.5 STAT3-Activity ................................................................................................... 13 3.0 Patient Eligibility .............................................................................................................. 14 3.1 Inclusion Criteria ................................................................................................. 14 3.2 Exclusion Criteria ................................................................................................ 15 3.3 Inclusion of Women and Minorities .................................................................... 15 4.0 Screening and Registration Procedures............................................................................. 16 4.1 Screening Procedures ........................................................................................... 16 4.2 Informed Consent ................................................................................................ 16 4.3 Registration Requirements/Process ..................................................................... 16 4.4 Randomization ..................................................................................................... 17 5.0 Treatment Program ........................................................................................................... 17 5.1 Treatment Overview ............................................................................................ 17 5.2 Pla nned Duration of Therapy ............................................................................... 18 5.3 Subject Follow- Up ............................................................................................... 18 5.4 Supportive Care, Other Concomitant Therapy, Prohibited Medications ............. 18 5.5 Additional Studies ................................................................................................ 18 6.0 D ose Delays/Modifications for Adverse Events ............................................................... 18 7.0 Data and Safety Monitoring, Unanticipated Problems and Adverse Event Reporting ..... 19 8.0 Agent Information and Risks ............................................................................................ 26 8.1 Sipuleucel –T (Provenge®) ................................................................................. 26 8.1.1 Sipuleucel-T overview ......................................................................................... 26 8.1.2 Leukapheresis and Collection of Quiescent APCs .............................................. 26 8.1.3 Qual ity Testing ....................................................................................................