Groundbreaking Clinical Trial Aims to Overcome Blood-Brain Barrier in Glioblastoma Treatment
Glioblastoma (GBM) remains one of the most aggressive and challenging brain cancers to treat. Despite ongoing advances in cancer treatment, no effective cure exists, and current therapies fall short of significantly prolonging survival. There’s a critical need for innovative therapeutic approaches. Moffitt Cancer Center’s neurosurgeons are leading a groundbreaking new clinical trial utilizing Carthera’s SonoCloud-9 technology. This novel approach has the potential to transform how drugs are delivered to the brain and improve outcomes for patients battling recurrent GBM.
Glioblastoma Standard of Care
Several therapies are typically utilized when treating glioblastoma. Surgical removal of the tumor mass via a surgical procedure called a craniotomy remains a crucial step in treatment. Neurosurgeons remove as much of the tumor mass as safely possible while preserving brain function. However, due to the invasive nature of GBM within normal, functioning brain, complete removal of the cancer cells is impossible, necessitating follow-up treatments such as chemotherapy and radiation. Unfortunately, the natural blood-brain barrier (BBB), which seals blood vessels in the brain, prevents most chemotherapy drugs from effectively reaching the remaining cancer cells.
Carthera’s SonoCloud-9 Technology
Dr. Michael Vogelbaum, Program Leader of Moffitt’s Department of Neuro-Oncology and its Chief of Neurosurgery, is leading a new clinical trial studying the Carthera SonoCloud-9 technology, an innovative implanted ultrasound device designed to enhance drug delivery to the brain. This system emits low-intensity pulsed ultrasound that, when combined with infused microbubbles, causes a transient opening of the BBB. This novel process allows intravenous chemotherapy, which is normally blocked from the brain to access brain tissue and reach infiltrative GBM cells with the hope that the increased drug penetration will improve treatment effectiveness.
Inside the Novel Clinical Trial
Moffitt Cancer Center is among the few institutions conducting this groundbreaking Phase III clinical trial designed specifically for patients with recurrent GBM. Researchers are evaluating the effectiveness of the Carthera SonoCloud-9 implantable ultrasound device when paired with carboplatin chemotherapy, compared to current standard treatments, including lomustine (CCNU) and temozolomide (TMZ).
The trial focuses on patients undergoing planned surgical resection for the first recurrence of GBM. Following the surgery, participants either receive the SonoCloud-9 implant and carboplatin chemotherapy or continue with standard second-line chemotherapy based on the physician’s discretion and best practice.
Impact of This New Treatment Option
The challenge to deliver effective drugs past the BBB has long been a significant hurdle in treating CNS tumors. This clinical trial is an important step forward, as SonoCloud-9 technology enhances how well chemotherapy penetrates the brain, addressing a key limitation in GBM treatment.
“Our field has finally accepted the fact that drug access to the CNS is the primary barrier to further progress in clinical care. This technology has been shown to improve drug penetration into the brain,” says Dr. Vogelbaum.
Currently, no therapeutics have proven to prolong survival in patients with recurrent GBM. However, this trial offers new hope by making chemotherapy more effective and providing a promising new treatment option for patients facing this disease.
A New Option for Recurrent Glioblastoma Patients
This clinical trial is a valuable opportunity for patients, medical oncologists, and neurosurgeons seeking innovative treatment approaches. The SonoCloud-9 technology opens the door for patients who previously had limited options.
Our experts at Moffitt Cancer Center continue to lead the fight against cancer, leveraging groundbreaking research and reinforcing our reputation as a leader in innovation and excellence. Through cutting-edge advancements like this and other clinical trials, Moffitt is transforming the future of cancer treatment and offering new hope to patients who need it.
Healthcare providers can refer eligible patients to Moffitt for this study.
If you’d like to refer a patient to Moffitt, complete our online form or contact a physician liaison for assistance. As part of our efforts to shorten referral times as much as possible, online referrals are normally responded to within 24 - 48 hours.
