Daniel Levitt, 38, from Sayville, Long Island, was one of the early patients in the United States to be enrolled in a Phase I clinical trial for one of the most aggressive forms of brain cancer – glioblastoma multiforme (GBM). The clinical trial being conducted at Lenox Hill Hospital is testing the safety and efficacy of a new targeted nanocell therapy which delivers chemotherapy drugs and at the same time, stimulates the patient’s own immune system to fight the tumor. The research is sponsored by EnGeneIC Pty Ltd.
Last February, Mr. Levitt was in bed and couldn’t move his toes on his left foot. Two weeks later, the symptoms got progressively worse. Mr. Levitt experienced a foot drop where the muscles in his leg couldn’t effectively raise the foot at the ankle. He was referred to an orthopedist, but imaging scans did not reveal any abnormality.
Mr. Levitt was then seen by a neurologist who recommended he undergo a brain scan, which revealed a GBM. Mr. Levitt’s wife researched online and came across a friend of the family who received treatment from John Boockvar, MD, a world-renowned expert in GBM and director of Lenox Hill’s Brain Tumor Center. After learning of his family friend’s positive experience with Dr. Boockvar, Mr. Levitt decided he was the neurosurgeon he wanted to see.
Upon reviewing the magnetic resonance imaging (MRI) scans, Dr. Boockvar was confident he would be able to remove most of the tumor. This past August, the surgery was a success as Dr. Boockvar removed his GBM.
“While Mr. Levitt’s surgery was successful, he also required additional treatment with radiation and chemotherapy,” said Dr. Boockvar. “We are always looking for new, effective and safe ways of delivering chemotherapy agents directly to the tumor site. In clinical trials, we have come a long way with intra-arterial drug delivery, but the challenge is that chemotherapy agents need to penetrate the blood brain barrier, which is a network of blood vessels that block foreign substances from entering the brain. In our new clinical trial, nanocell-based technology allows us to passively target the tumor by getting access through the tumor’s leaky vessels.”
Lenox Hill’s study entitled, “A Phase I study to evaluate the safety, tolerability and immunogenicity of EGFR (Vectibix sequence)-targeted EDV’s containing doxorubicin (EGFR (V)-EDV-Dox) in subjects with recurrent glioblastoma multiforme,” is being led by Dr. Boockvar and Marc Symons, PhD, a professor at the Feinstein Institute for Medical Research.
The EnGeneIC Dream Vector (EDVTM), a nanocell-based technology, is a new way of delivering chemotherapy drugs and other therapeutic molecules for the treatment of brain tumors. Dr. Boockvar and his colleagues at the Feinstein Institute’s Brain Tumor Biotech Center are also working with EnGeneIC to do preclinical studies in animal models of GBM in addition to this human clinical trial.
In this study, the EDVs are delivered in a weekly 20-minute intravenous infusion, for seven consecutive weeks to patients with recurrent GBM. In addition to testing the safety and tolerability, a secondary objective of the study is to analyze how the body’s immune and inflammatory system reacts to the treatment.
Mr. Levitt has completed his first seven treatments. Subsequent MRI’s have shown that there is no additional growth of the tumor and even some shrinkage.
“Dr. Boockvar has been by far the greatest turning point in my brain cancer care and has taken a highly proactive approach from the first moment I met with him,” said Mr. Levitt. “In my case, Dr. Boockvar used both surgical and clinical trial treatment options to combat my glioblastoma. My quality of life has notably improved and for the first time since my initial diagnosis, I have hope and a positive outlook. My family and I have the greatest respect and gratitude for Dr. Boockvar and his team.”
For more information about this clinical trial, please call Tamika Wong, MPH at 212-434-4836 or firstname.lastname@example.org.
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