Verweij. New response evaluation criteria in solid tumors: Revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. Protocol Version 8.0. September 19 , 2018 Page | 63 11.4 Pharmaceutical Information for Ad.p53- DC Vaccine A. Generation of Ad. p53 DC vaccine Mononuclear cells for the production of dendritic cells (DC) will be obtained through a single apheresis procedure and stored in liquid nitrogen at the Moffitt Cancer Center . After collection through apheresis, the product will be enriched for mononuclear cells via density centrifugation using Ficoll. The enriched product will be cryopreserved in 3 – 4 fractions and stored in cryoprotectant in va lidated LN2 freezers. Approximately one week prior to each scheduled vaccination, one fraction of cells will be thawed by the Moffitt Cell Therapy Facility staff and placed in CellGenix DC Medium in tissue culture flasks at a concentration of 1.3 – 1.7x10 6 cells/cm2. After culturing for 1.5 – 2 hours in a 37 C, 5%CO2 incubator , non-adherent cells will be removed . Fresh DC Medium supplemented with 100 ng/ml GM - CSF and 50 ng/ml IL -4 will be added . Cells will be cultured for approximately 5 days in a 37 C, 5%CO2 incubator. At the completion of incubation, non- adherent and loosely adherent cells will be c ollected and transduced with Ad.p53 for 2 – 3 hours at a concentration of approximately 10x106 cells/ml. At the completion of the transduction, cells will be diluted 10 fold with medium supplemented with 5 ng/ml GM -CSF and 5 ng/ml IL -4. Transduced cells will be cultured for approximately 40 hours in a 37 C, 5%CO2 incubator, then harvested, washed and analyzed prior to administration. Vaccines will not be released for patient use until release criteria are met. Release criteria for vaccine administration include: Test Criteria Mycoplasma Negative Gram Stain No Organisms Seen Endotoxin < 5 EU/kg Phenotype > 10% DC expressing p53 Dose 1 – 5x106 viable p53+ DC The vaccine cell suspension will be injected intra -dermally (or subcutaneously) into 4 separate sites to include proximal upper and lower extremities (in the regions of the axillary and inguinal nodal basins. The patients will be monitored in the Clini cal Research Unit at the H. Lee Moffitt Cancer Center for acute toxicity for 1 hour after their injections. Protocol Version 8.0. September 19 , 2018 Page | 64 11.5 Management Algorithms These general guidelines constitute guidance to the Investigator and may be supplemented by discussions with the Medical Monitor representing the Sponsor. The guidance applies to all immuno -oncology agents and regimens. A general principle is that differential diagnoses should be diligently evaluated according to standard medical practice. Non- inflammatory etiologies shou ld be considered and appropriately treated. Corticosteroids are a primary therapy for immuno -oncology drug- related adverse events. The oral equivalent of the recommended IV doses may be considered for ambulatory patients with low -grade toxicity. The lower bioavailability of oral corticosteroids should be taken into account when switching to the equivalent dose of oral corticosteroids. Consultation with a medical or surgical specialist, especially prior to an invasive diagnostic or therapeutic procedure, is recommended . The frequency and severity of the related adverse events covered by these algorithms will depend on the immuno-oncology agent or regimen being used. NOTE: In cases of an -expected or unforeseen discrepancy between the guidelines or instru ctions in Table 3 (below) and Section 11.6 Management Algorithms, the latter guidelines/instructions should prevail for the purposes of patient management on protocol. Protocol Version 8.0. September 19 , 2018 Page | 65 Protocol Version 8.0. September 19 , 2018 Page | 66 Protocol Version 8.0. September 19 , 2018 Page | 67 Protocol Version 8.0. September 19 , 2018 Page | 68 Protocol Version 8.0. September 19 , 2018 Page | 69 Protocol Version 8.0. September 19 , 2018 Page | 70 Protocol Version 8.0.