[Safety of an XXXX deleted adenovirus administered intratumorally to @entity1 with @entity5 ].

@entity1 @entity137 @entity5 @entity6860 @entity158 @entity221
BACKGROUND _ OBJECTIVE: In recent years, great development has been made in @entity5 therapeutics with replication-competent viruses (oncolytic viruses). Genetically modified adenovirus is one of promising viruses. The current study was designed to evaluate the safety of intratumoral H101, an @entity6860 deleted adenovirus. METHODS: A total of 15 @entity1 with @entity5 were treated with H101 in a dose-escalation manner (from 5 x 10(7) VP to 1.5 x 10(12) VP per day for 5 consecutive days). Systemic examination was performed prior to injection. Physical signs (including weight, temperature, respiration,pulse, and blood pressure) and @entity137 were observed and recorded carefully during treatment. Adenoviral DNA in plasma, urine, and swabs of oropharynx, swabs of the injection site from different time-point were determined by PCR. RESULTS: Evaluation of @entity137 in all 15 cases was available. All @entity1 tolerated well following intratumoral injection of H101. Dose limited @entity137 (DLT) and serious adverse event (SAE) were not found in the course of treatment. Main side effects were injection site @entity158 (60.0%) and @entity221 (33.3%). Adenoviral DNA was undetectable in plasma, urine, and swabs of oropharynx, swabs of the injection site. CONCLUSION: This study showed that the @entity137 of intratumoral injection of @entity6860 deleted adenovirus (H101) were lower and tolerable. There is no evidence indicating the invasion. These results suggested that intratumorally injected H101 is safe.
