A phase I trial of lenalidomide and radiotherapy in children with diffuse intrinsic pontine gliomas or high-grade glioma

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CLINICAL STUDY

A phase I trial of lenalidomide and radiotherapy in children with diffuse intrinsic pontine gliomas or high‑grade gliomas Sean J. Hipp1   · Stewart Goldman2 · Aradhana Kaushal3 · Andra Krauze4 · Deborah Citrin5 · John Glod6 · Kim Walker6 · Joanna H. Shih7 · Hema Sethumadhavan6 · Keith O’Neill6 · James H. Garvin8 · Julia Glade‑Bender8,9 · Matthias A. Karajannis9,10 · Mark P. Atlas11 · Arman Odabas6 · Louis T. Rodgers6 · Cody J. Peer12 · Jason Savage5 · Kevin A. Camphausen5 · Roger J. Packer13 · W. Douglas Figg6 · Katherine E. Warren6,14 Received: 27 August 2020 / Accepted: 18 September 2020 © This is a U.S. Government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2020

Abstract Purpose  This study was performed to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of the immunomodulatory agent, lenalidomide, when administered daily during 6 weeks of radiation therapy to children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) Patients & methods  Children and young adults