Phase I/II trial of vorinostat and radiation and maintenance vorinostat in children with diffuse intrinsic pontine glioma: A Children’s Oncology Group report

Publication Citation

Su JM, Kilburn LB, Mansur DB, Krailo M, Buxton A, Adekunle A, Gajjar A, Adamson PC, Weigel B, Fox E, Blaney SM, Fouladi M. Phase I/II trial of vorinostat and radiation and maintenance vorinostat in children with diffuse intrinsic pontine glioma: A Children’s Oncology Group report. Neuro Oncol. 2022 Apr 1;24(4):655-664. doi: 10.1093/neuonc/noab188. PubMed PMID: 34347089; PubMed Central PMCID: PMC8972206.

Abstract

A phase I/II trial of vorinostat (suberoylanilide hydroxamic acid), an oral histone deacetylase inhibitor, was conducted in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) through the Children’s Oncology Group (COG) to: 1) determine the recommended phase II dose (RP2D) of vorinostat given concurrently with radiation therapy; 2) document the toxicities of continuing vorinostat as maintenance therapy after radiation; and 3) to determine the efficacy of this regimen by comparing the risk of progression or death with a historical model from past COG trials. Vorinostat was given once daily, Monday through Friday, during radiation therapy (54 Gy in 30 fractions), and then continued at 230 mg/m2 daily for a maximum of twelve 28-day cycles.

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