Boca Raton Regional Hospital announces that it has initiated a clinical trial examining the potential therapeutic role of the immunotoxin MDNA55 in the treatment of patients with recurrent malignant brain tumors.
The Marcus Neuroscience 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.
This is a phase two trial that examines the potential role of an immunotoxin that is highly toxic to brain tumor cells. MDNA55 targets a cytokine, IL-4 (interleukin 4), which is found on the surface of most recurrent brain tumors. MDNA55 is a protein derived from pseudomonas aeruginosa, a bacterium associated with pneumonias and skin, tissue and urinary tract infections. MDNA55 is considered a targeted therapy because it is made to attach only to tumor cells. Most of normal brain cells have no IL-4 expression. Therefore, the trial aims to kill brain tumor cells, while not harming healthy cells.
The immunotoxin is delivered to the tumor by what is called Convection Enhanced Delivery or CED. CED is 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 unique 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. In previous studies, complete or partial responses were seen in 56 percent of patients with these tumors,” said Dr. Vrionis. “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.”
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,” said Dr. Chowdhary. “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.”
The MDNA55 trial is one of 10 at Boca Regional’s Marcus Neuroscience and Lynn Cancer Institutes that are investigating brain tumors, and part of a burgeoning clinical research initiative between the Hospital and Florida Atlantic University’s Charles E. Schmidt College of Medicine.
Interested patients or referring physicians can learn more about the MDNA55 trial and enrollment by contacting Boca Raton Regional Hospital’s Office of Research at 561.955.4800.
About the Marcus Neuroscience Institute
The Marcus Neuroscience Institute at Boca Raton Regional Hospital is an innovative nexus for neurologic and neurosurgical care. The 57,000-square-foot facility houses a 20-bed Neuro Intensive Care and Step-Down Unit, four dedicated operating rooms — including one equipped with intraoperative MRI and two with intraoperative CT capability — and a biplane angiography suite, a crucial component in the diagnosis and care of neurological conditions.