Safety of pioglitazone during and after radiation therapy in patients with brain tumors: a phase I clinical trial.

ABSTRACT:

Introduction

Radiation-induced cognitive decline (RICD) is a late effect of radiotherapy (RT) occurring in 30-50% of irradiated brain tumor survivors. In preclinical models, pioglitazone prevents RICD but there are little safety data on its use in non-diabetic patients. We conducted a dose-escalation trial to determine the safety of pioglitazone taken during and after brain irradiation.

Methods

We enrolled patients > 18 years old with primary or metastatic brain tumors slated to receive at least 10 treatments of RT (≤ 3 Gy per fraction). We evaluated the safety of pioglitazone at 22.5 mg and 45 mg with a dose-escalation phase and dose-expansion phase. Pioglitazone was taken daily during RT and for 6 months after.

Results

18 patients with a mean age of 54 were enrolled

SUBMITTER: Cramer CK 

PROVIDER: S-EPMC6805132 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature