The first patient in the world’s first clinical trial using focused ultrasound to open the blood-brain barrier (BBB) and allow chemotherapeutic agents to more efficiently reach the tumors of patients with glioblastoma (GBM) has completed treatment at Severance Hospital, a part of Yonsei University Health System, in Seoul, Korea.
According to the study’s protocol, patients receive six cycles of treatment, which include disrupting the BBB during adjuvant chemotherapy dosing.
This safety and feasibility study is evaluating the use of Insightec’s Exablate Neuro device for BBB disruption in 10 patients with GBM who are eligible for adjuvant temozolomide (TMZ) chemotherapy based on the current standard of care for GBM. The first patient was enrolled in August 2018 and completed all six cycles without any recurrence of the tumor or incurring any side effects or complications from the BBB disruption.
“This study builds on earlier work done at Sunnybrook Health Sciences Centre in Toronto and at Carthera in Paris,” says Jin-Woo Chang, MD, PhD, the trial’s Principal Investigator. “We are excited to continue this effort with the addition of the chemotherapy, and it is the first time in the world that it is being done by the opening BBB every 6 months without causing any issues for the patient using the ExAblate non-invasive system.”
“Professor Chang and his team continue to provide great leadership with advancing focused ultrasound clinically,” said Foundation Chairman Neal F. Kassell, MD. “We continually see the worldwide effect of work that begins in Korea, and this study should be no exception.”
GBM is one of the most aggressive malignant tumors with an overall dismal survival averaging one year despite multimodality therapeutic interventions including surgery, radiotherapy, and concomitant and adjuvant chemotherapy. The addition of TMZ to standard therapy only increases the median survival by approximately 2.5 months. Therefore, there is a crucial demand for improving overall patient survival with new and innovative therapeutic methods.
Information for Patients
Patients interested in participating in this study should contact:
Martin Bernstein at +97248131313 ext 628 or or Kathy L. McDermott at +12146302000.
For additional information, please see clinicaltrials.gov (NCT03712293).