This article reports the results of a Phase I single-institution, open-label, dose-escalation, safety and tolerability study of IL13-PE38QQR infused via convection-enhanced delivery into tumors in 5 pediatric patients with diffuse intrinsic pontine glioma. Clinical safety, imaging, and outcome methods from this trial could be used in future clinical trials.
ABBREVIATIONSCED = convection-enhanced delivery; DIPG = diffuse intrinsic pontine glioma; IL-13 = interleukin 13; IL13R = IL-13 receptor; IPI = Impact of Pediatric Illness; KPS = Karnofsky Performance Status; LPS = Lansky Performance Status; MRS = MR spectroscopy; NAA = n-acetyl aspartate; QOL = quality of life; Vd = volume of distribution; Vi = volume of infusion.
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