DIPG Clinical Trial Continuation Wins FDA Approval

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07-14-2014

The Food and Drug Administration (FDA) has approved a continuation of Dr. Mark Souweidane’s Phase 1 clinical trial for diffuse intrinsic pontine glioma (DIPG). The original clinical trial, which began in May 2012, has treated 14 patients using convection-enhanced delivery (CED) of a therapeutic agent in increasing dose levels; the approved continuation adds three additional dose levels. The approval re-opens the trial for new patient enrollment.

The clinical trial for DIPG, which was developed in Dr. Souweidane’s research lab at Weill Cornell and is being conducted at Memorial Sloan-Kettering Cancer Center (MSKCC), takes a new approach to delivering cancer-fighting drugs to a pediatric brain tumor. Chemotherapy historically has limited effectiveness on brain tumors since drugs delivered to the bloodstream (either in pill form or via IV drip) cannot cross the protective blood-brain barrier. In Dr. Souweidane’s trial, a therapeutic agent is delivered directly to the tumor by way of a tiny catheter. See more details about the clinical trial for DIPG.

The DIPG clinical trial is one of the research efforts of the Children’s Brain Tumor Project at Weill Cornell Brain and Spine Center. Find out more about the Children’s Brain Tumor Project.

The trial admits patients between ages 3 and 21 who meet certain inclusion criteria. Additional details about the criteria for inclusion in the DIPG clinical trial can be found at clinicaltrials.gov

Find out more about Dr. Souweidane’s research.