UNC Health is the first site in the country to begin enrolling patients in a multicenter, multinational phase III clinical trial, evaluating a more effective way to deliver chemotherapy to the brain and if it can improve overall survival for glioblastoma patients.
SONOBIRD is the name of the phase III clinical trial using a device called SonoCloud®. The goal of the device is to more effectively deliver chemotherapy through the brain to treat malignant brain tumors. The SonoCloud® phase III clinical trial is for glioblastoma patients with their first recurrence. In this trial, the SonoCloud® device, developed by Carthera®, is implanted at the time of surgery delivering focused ultrasound waves to the tumor. This increases the delivery of chemotherapies to the brain tumor tissue.
Both phase I and II studies of the implanted focused ultrasound device showed that the treatment was safe and well-tolerated by patients. The phase III clinical trial will continue to evaluate whether the treatment offers improved overall survival compared with the standard of care. UNC Health is the only site in the United States that is activated for the SONOBIRD phase III clinical trial and is actively enrolling patients in this clinical trial.
Dr. Dominique Higgins, director of adult neurosurgical oncology at UNC Health, will lead the study. “We are proud to be the first in the continent to offer this clinical trial to our patients with recurrent GBM,” said Dr. Higgins. “Focused ultrasound is a promising technology, and we look forward to collaborating with our partners around the globe on this exciting endeavor.”
During a brain tumor resection surgery, the overlying bone is usually removed to access the tumor. In this clinical trial, once the tumor is removed, a titanium mesh with small focused ultrasound transducers designed to send ultrasound waves directly to the tumor location is put in place of the bone. When the device is activated, these ultrasound waves disrupt the barrier that prevents drugs from getting from the blood to the brain tumor, allowing local delivery of the treatment at a higher concentration without increased systemic side effects.
Dr. Soma Sengupta, Division Chief of Neuro Oncology at UNC Health, and Dr. Yasmeen Rauf, neuro oncologist at UNC Health, will work with Dr. Higgins on the study. Both neuro-oncologists feel results from this study has the potential to impact future targeted therapies for glioblastoma patients.
SONOBIRD is one of multiple glioblastoma clinical trials at UNC Health. The average survival rate for patients diagnosed with glioblastoma is less than two years. Ongoing brain tumor research at the UNC Lineberger Comprehensive Cancer Center in Chapel Hill aims to change that. This clinical trial has the potential to make a huge impact on glioblastoma treatment, and on the lives of glioblastoma patients and their families.
About UNC Lineberger Comprehensive Cancer Center
The UNC Lineberger Comprehensive Cancer Center is a cancer research and treatment center at the University of North Carolina at Chapel Hill. UNC Lineberger Comprehensive Cancer Center provides access to cutting edge clinical trials for patients with brain tumors to understand how to better treat aggressive brain tumors, including glioblastoma. UNC Lineberger is the only public comprehensive cancer center in the state of North Carolina.
About Carthera®
Carthera® is headquartered in Lyon, France and works closely with renowned academic institutions worldwide to revolutionize the outlook of brain disease treatments. Founded in 2010, Carthera® is a clinical-stage company with its SonoCloud® implant that temporarily opens the blood-brain barrier.
If you would like to request to join the study at UNC Health, please email the study coordinator, Camisha Johnson, at camisha_johnson@med.unc.edu or visit clinicaltrials.gov for more information.