Patient monitoring
toxicity, Toxicities, Toxicity, Cancer
ADVERSE EVENTS, ADENOVIRUS, CANCER
Toxicity assessments were performed once a week prior to the start of chemotherapy (first 3 weeks) and then at scheduled follow-up visits at 3, 6, 9, 12, 18, and 24 months. Toxicities were graded using the National Cancer Institute’s Common Toxicity Criteria, CTCAE v.4.03. Case report forms (CRFs) specifically designed for this trial were used to document adverse events (AEs). The study was monitored by an internal Data and Safety Monitoring Board (DSMB). The primary end point, treatment toxicity, was monitored up to and including day 30. After treatment, patients received standard urologic care.The following evaluations were conducted once a week following the adenovirus injection through day 30: (i) physical examination, (ii) blood chemistries and complete blood counts including peripheral blood mononuclear cells (PBMC) (iii) serum PSA, (iv) presence of Ad5-IL-12 viral DNA and infectious adenovirus in blood, (v) cytokines including IL-12, CXCL10 and IFNγ, and (vi) performance status. The presence of Ad5-IL-12 viral DNA in blood, serum IL-12, IFNγ, and CXCL10 levels were monitored at every blood draw until not detected in two consecutive measurements.