The contents of five such vials should be distributed into 5 syringes. Because it is not possible to remove a full 1mL from each vial after thawing, a minimum of 0.8- mL should be drawn into each of the 5 syringes. In the case of LNCaP , each vile is also filled with 1mL of cells in suspension. The contents of three such vials should be distributed into 5 syringes. Because it is not possible to remove a full 1mL from each vial after thawing, approximately 0.5 -mL s hould be drawn into each of the 5 syringes. Every attempt should be made to use the entire content of three vials of LNCaP cells, distributed among these 5 syringes ( i.e. none of the LNCaP cells should be discarded). The immunotherapy clinical lots were manufactured and released by the Cell Processing and Gene Thera py Facility, a cGMP -compliant facility, at t he Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The manufacturing and product release data for the PC3 and LNCaP cell lines were submitted to the FDA prior to initiating this study. Androgen suppression with prostate GVAX and cyclophosphamide J1265 Johns Hopkins University 29 of 68 J1265 PROT (Vers) 1.4 113012 The transduced cells are irradiated prior to cryopreservation and stored frozen in the vapor phase of liquid nitrogen until the day of use. The cryoprotectant is in an injectable formulation: 6% hetastarch (in 0.9% sodium chloride) supplemented with 2% human serum albumin and 5% DMSO. The cell lines used for the vaccine preparation have undergone extensive regulatory testing and have been determined to be sterile and free of viral contamination. The details of production, irradiation, freezing, and preparation for administration are described in detail in the Investigational New Drug (IND) submission. Released vials of the AAV genomic GM -CSF–transduced PC3 Clinical Lot an d the AAV genomic GM -CSF–transduced LNCaP Clinical Lot w ill be transferred from the Cell Processing and Gene Therapy Facility to the CTL in a ‘dry’ liquid nitrogen shipper. The vials will be stored in a vapor -phase liquid nitrogen freezer until use, in accordance with existing standard operating procedures. The freezer is alarmed and monitored using a n R & D Datatron System. Administration of the cells will be given as intradermal injection s using a 22 -gauge needle and must be administered within 75 minutes from the time that the vials have thawed. Each cell line should be administered on a separate leg. Injections should use the upper portion of the thigh. Injections should be placed randomly, approximately 2 inches apart from each other. If the patient is unable to receive an injection in the legs, an acceptable alternative injection site is the abdomen. Do not place injections into skin that is ulce rated or infected. Patients must remain in the clinic for observation for ≥60 minutes following vaccination. A lidocaine -based t opical anesthetic cream ( e.g. EMLA or ELA- MAX) will be recommended to be applied to each injection site approximately 1 -2 hours (up to 2.5 hours) prior to vaccination to diminish the discomfort associated wi th the intra - dermal injections. The topical anesthetic is optional and participants are allowed to decline its use. Self -application of the topical anesthetic is allowed after the research participant receives instruction. If the research participant is non -compliant with topical anesthetic administration instructions, the topical anesthetic will be applied by the research nurse. If the subject is allergic to lidocaine, the topic al anesthetic should not be used. All research participants will be seen in the Oncology Outpatient Center for immunotherapy administration and monitoring. 6.1.2 Potential Toxicities Toxicities will be assessed using the most recent National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 4.0 – see Appendix B ). 6.1.2.1 Potential Toxicities of the Storage Solutions Dimethyl Sulfoxide (DMSO) The prostate GVAX v accine is cr yopreserved in a solution containing approximately 5% DMSO . DMSO is a cryoprotectant used to store a variety of infused cell products including hematopoietic stem cells and bone marrow. After cells are thawed, DMSO contained in the freezing solution is infused along with the cells. Toxicity associated with DMSO infusion is usually limited to minor changes in heart rate, blood pressure, fever, chills, sweats, n ausea, vomiting and headaches. These are usually self-limited, la sting no more than a few hours. The most notable effect is a garlicky Androgen suppression with prostate GVAX and cyclophosphamide J1265 Johns Hopkins University 30 of 68 J1265 PROT (Vers) 1.4 113012 odor due to exhalation of a DMSO metabolit e that may last up to one day. More severe adverse effects include severe acute allergic reactions including anaphylactoid reactions, pulmonary embolism, respiratory failure, ren al failure, cardiac arrhythmias, seizures, and death . These side effects are rarely observed and occur primarily in patients receiving much higher volumes of cryopreserved cell products than being infused in the present study. Nevertheless, patients will b e carefully monitored for any adverse effects as outlined in Section 7.