Study objectives and assessment
toxicities, tumor, Cancer
ADVERSE EVENT, VIRUS, TUMOR, ADVERSE EVENTS, SECONDARY, CANCER
The primary objective of this study was to determine a recommended dose of Olvi-vec. The secondary objectives included the assessment of feasibility, safety and tolerability, evaluation of viral presence in the tumor, pleural fluid, serum, sputum, and urine, and evaluation of anti-vaccinia virus immune response. All patients were included in the reporting of adverse events (AEs). The safety of Olvi-vec was assessed by the evaluation of the type, frequency, and severity of AEs, changes in clinical laboratory tests (hematological and chemistry), immunogenicity, and physical examination. All AEs and laboratory toxicities were graded using the Common Terminology Criteria for Adverse Events (National Cancer Institute, version 4.0). Laboratory testing was performed at baseline (i.e., within 14 days before treatment), daily during the first 3 days after treatment, and at termination of study (day 60 ± 5).