By: Dale King Contributing Writer
Boca Raton Regional Hospital, through its Marcus Neuroscience Institute, has begun a clinical trial examining the potential therapeutic role of the immunotoxin MDNA55 in the treatment of patients with recurrent malignant brain tumors.
The Institute is the only site in the southeastern United States to be conducting this specific study. It is headed by nationally recognized specialists Frank Vrionis, MD, MPH, PhD, director of Boca Regional’s Marcus Neuroscience Institute, and Sajeel Chowdhary, MD, director of Neuro-Oncology at the Institute.
Highly toxic to brain tumor cells. MDNA55 targets a cytokine, IL-4 (interleukin 4) found on the surface of most recurrent brain tumors. Use of MDNA55 is considered a targeted therapy because it is made to attach only to tumor cells. Most normal brain cells have no IL-4; therefore, the trial aims to kill brain tumor cells while not harming healthy cells.
The immunotoxin is delivered by what is called Convection Enhanced Delivery (CED), a therapeutic strategy that facilitates targeted introduction of pharmaceuticals to the brain through tiny catheters implanted in the tumor for several hours. CED ensures that the drug covers the entire tumor and bypasses what is known as the blood-brain barrier.
The blood-brain barrier functions as the brain’s own security system by allowing entry of nutrients while blocking other substances. Unfortunately, it also serves as a major impediment to traditional chemotherapy.
With the Marcus Neuroscience Institute’s specialized intraoperative MRI, the drug infusion can be monitored in real-time during surgery and any leakage outside the target area can be modified immediately.
“Research to date on the therapy has been encouraging,” Dr. Vrionis said. “In previous studies, complete or partial responses were seen in 56 percent of patients with these tumors.”
“Given those promising results, this therapy has received fast-track designation by the FDA, which expedites the development and review of drugs through trials such as ours.”
But because of the infiltrative nature of these malignancies and the complexity of the brain itself, these tumors are highly refractory to treatment and a complete cure can be extremely difficult.
“Recurrences, regretfully, are the norm despite radiotherapy, surgery and chemotherapy,” Dr. Chowdhary said. “When they occur, options are limited, as most patients have already received all known available treatments. Our investigation into the use of immunotherapy for them is of the utmost importance and has the potential to pay great dividends.”