A Phase I Trial and Viral Clearance Study of Reovirus (Reolysin) in Children with Relapsed or Refractory Extra-cranial Solid Tumors: A Childrens Oncology Group Phase I Consortium Report

摘要

PurposeReovirus is a naturally occurring human virus that is cytopathic to malignant cells possessing an activated Ras signaling pathway. We conducted a phase I trial of Reolysin, a manufactured, proprietary isolate of purified reovirus, in children with relapsed/refractory extracranial solid tumors to define the recommended phase 2 dose (RP2D), toxicities and pharmacokinetic properties when administered as a single agent or in combination with cyclophosphamide.