Clinical Trials Resource Center

Brain Tumor (Pediatric)

November 7, 2011

YM Biosciences reported preliminary results from a phase II trial of nimotuzumab for pediatrics with recurrent diffuse intrinsic pontine glioma. This open-label, single-arm, multi-center study enrolled 46 subjects aged three to 18 years of age. The subjects received nimotuzumab 150 mg/m2 administered intravenously once weekly from week one to seven and once every two weeks from week eight to 18. Treatment with nimotuzumab was well tolerated with most adverse events reported as mild or moderate in severity. No complete responses (CR) were observed. At week eight, a partial response (PR) was reported in two subjects, stable disease (SD) in six subjects and progressive disease (PD) in 11 subjects who were evaluable for response, resulting in a clinical benefit rate (CR+PR+SD) of 18.2%. At week 18, one subject continued to have a PR and three subjects continued with SD, for an overall response rate of 2.3%. The median duration of response, time to progression, and overall survival were 2.1 months, 1.7 months and 3.2 months respectively.

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