title: [Safety of an E1B deleted adenovirus administered intratumorally to patients with cancer].
abstract: OBJECTIVE
  In recent years, great development has been made in cancer 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 E1B deleted adenovirus.
  
  
  METHODS
  A total of 15 patients with malignant tumors 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 toxicity 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 toxicity in all 15 cases was available. All patients tolerated well following intratumoral injection of H101. Dose limited toxicity (DLT) and serious adverse event (SAE) were not found in the course of treatment. Main side effects were injection site pain (60.0%) and fever (33.3%). Adenoviral DNA was undetectable in plasma, urine, and swabs of oropharynx, swabs of the injection site.
  
  
  CONCLUSIONS
  This study showed that the toxicities of intratumoral injection of E1B deleted adenovirus (H101) were lower and tolerable. There is no evidence indicating the invasion. These results suggested that intratumorally injected H101 is safe.
authors.affiliation: Cancer Center, Sun Yat-sen University, Guangzhou, Guangdong, 510060, P.R. China.
authors.forename: Zhong-Yu
authors.initials: ZY
authors.lastname: Yuan
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.forename: Su
authors.initials: S
authors.lastname: Li
authors.forename: Xiao-Zhou
authors.initials: XZ
authors.lastname: Qian
authors.forename: Zhong-Zhen
authors.initials: ZZ
authors.lastname: Guan
mesh_terms: D000256:Adenoviridae / Q000235:genetics / Q000502:physiology*; D000257:Adenoviridae Infections; D017501:Adenovirus E1B Proteins / Q000172:deficiency* / Q000235:genetics; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy* / Q000821:virology; D030781:Organisms, Genetically Modified / Q000502:physiology*
chemical_list: D017501:Adenovirus E1B Proteins