A phase I clinical trial of an adenovirus-mediated endostatin gene (E10A) in patients with solid tumors

• DOI: 10.4161/cbt.6.5.4004
• Publication Date: 2010-06-09T21:31:25Z
• Authors: Xubin Lin; Huiqiang Huang; Su Li; Hongli Li; Yuhong Li; Ye Cao; Dongsheng Zhang; Yunfei Xia; Ying Guo; Wenlin Huang; Wenqi Jiang
• Keywords: Endostatin

PurposeThe purpose of the current study were to assess safety and feasibility repetitive intratumoral administration E10A, an adenoviral vector encoding wild-type endostatin gene, patients with solid tumors, evaluate its biologic effect pharmacokinetics endostatin.MethodsPatients treated escalating doses from 1×1010 VP 1×1012 E10A intratumorally on days 1 8. Patients assessed for toxicity viral shedding, antitumor response was evaluated by imaging techniques tumor biopsy. Circulating levels examined.ResultsFifteen received 29 injections E10A. No dose-limiting developed, maximum tolerated dose had not yet been reached. Fever local reaction injection site common, but rarely severe. Mild transient hepatotoxicity observed in one patient. Minor injected achieved improvement control patient nasopharyngeal carcinoma, necrosis occurred two patients. Sustained elevation serum detected.ConclusionWeekly up is a feasible well-tolerated procedure that exerts mild effects. A small sustained endogenous blood possibly has activity.