An Update on the CERN Foundation's Clinical Trials

CERN Supported Research Uses New Approach to Calculate Drug Doses for Ependymoma Treatment

St. Jude Children’s Research Hospital scientists have used sophisticated pharmacologic modeling and simulation to translate preclinical findings into a phase I clinical trial of a chemotherapy, 5-FU, for ependymoma treatment. The research marked the first time the approach has been used to calculate drug doses for a clinical trial in pediatric brain tumor patients. Supported by the CERN Foundation.

"The approach used in this study should serve as a template for drug development, especially for rare diseases like ependymoma where the need for promising therapies is high but few patients are available for clinical trials," said corresponding author Clinton Stewart, Pharm.D., a member of the St. Jude Department of Pharmaceutical Sciences.

To read the full EurekAlert Article, click here.

Clinical Trials Update

Mark Gilbert, M.D., the Principal Investigator for the CERN Foundation’s adult clinical trials, also serves as the chief of the Neuro-Oncology Branch at the National Institutes of Health (NIH), within the Center for Cancer Research at the National Cancer Institute (NCI). The Neuro-Oncology Branch is a joint program of the National Institute of Neurological Disorders and Stroke. The branch conducts clinical trials, measures patient outcomes and develops best practices in patient care.

In this position, Dr. Gilbert is able to conduct collaborative and translational research focused on finding new treatment strategies for patients with malignant primary brain tumors. Specifically, his adult ependymoma research with the CERN Foundation, which includes completing the phase II clinical trial CERN 09-02, has been folded into the ongoing research in the Neuro-Oncology Branch, as part of a rare central nervous system cancer initiative. The initiative was started by Dr. Gilbert as a subset of the Rare Tumor Initiative at the NCI Center for Cancer Research. The research program gives investigators the opportunity to focus resources and efforts on diseases that have less than 1,000 patients diagnosed in the U.S. each year.

Living Each Day to the Fullest

CERN Inspiration Story

By Rachel (Sophia’s Mom)

In January 2016, my four-year-old daughter, Sophia, fell on the playground at school. When she got home that day, I noticed she was limping a little, not bearing weight on her left leg and hunching over a bit. I figured I would keep her home from school a few days and just watch it closely to see if it improved. That same night, it all went downhill. She woke up in the middle of the night screaming and crying in pain. She said her stomach and leg hurt and she wouldn’t lay on her back. Her dad and I comforted her and held her, but this cry was like nothing I’ve heard before from her.

Two days later, she was still waking up in the night with severe pain, so we brought her to the emergency room. We told the doctor about her symptoms and how she would wake up in extreme pain. He said it was most likely from the accident and she probably pulled something in her back, a musculoskeletal strain. We went home still feeling like something wasn’t adding up. Two days later after her pain increased, we were back in the emergency room. This time at a different hospital. An x-ray was ordered, but they saw nothing present and thought her abdominal pain was most likely a stomach ache or gas – so we were sent home again. Feeling frustrated, I made an appointment with her pediatrician. He couldn’t determine why she was waking up at night and why she was having the symptoms she was. He sent us to an orthopedic doctor who ordered an x-ray. The results from the x-ray showed that her spinal cord was expanded and he sent her for an MRI.

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