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JFK (Edison, NJ )Becomes First East Coast Site to Open Clinical Trial of New Treatment Under Investigation for Aggressive Brain Tumors

Posted on: 02/09/2012



JFK Becomes First East Coast Site to Open Clinical Trial of


New Treatment Under Investigation for Aggressive Brain Tumors

New Jersey – JFK’s Brain Tumor Center is the first east coast hospital to start enrolling patients into a clinical trial for Toca 511 & Toca FC, a combination therapy under investigation for high-grade glioma (HGG).  HGG is an aggressive brain cancer that typically recurs despite maximal therapy including surgery and chemoradiation.
The investigational treatment combines Toca 511 (vocimagene amiretrorepvec), an innovative  biologic drug, with Toca FC, an extended-release tablet containing the antibiotic flucytosine. “I was impressed by the published data to date on the mechanism by which the drug incorporates into the tumor cells,” said  Joseph C. Landolfi, D.O., director of the JFK Brain Tumor Center. We are offering several trials for the treatment of newly diagnosed glioblastoma multiforme. This trial allows us to expand the novel therapies available to include a broader range of patients as the Toca 511 is available to all recurrent HGG patients.
Standard treatment of HGG begins with surgery to remove as much of the tumor as possible, and is followed by radiation therapy, and chemotherapy.  Although the goal of standard treatment is to eliminate the tumor, the cancer usually returns because the tumor cells blend with and infiltrate healthy brain tissue.
In this clinical study, immediately after surgeons remove as much of the recurrent high-grade glioma as possible, the biologic drug Toca 511 will be injected into the “bed,” or portion of the brain from which the tumor was removed.
About seven weeks later, each patient will begin an eight-day course of oral Toca FC tablets. If tolerated well, these eight-day courses will be repeated every eight weeks for a total of three rounds during the six-month study. An MRI scan will be performed every two months during the trial period to measure the treatment’s effectiveness.
According to Tocagen, Inc., the San Diego-based biotechnology company that developed the investigational treatment, Toca 511 is designed to selectively deliver to cancer cells the genetic instructions to produce the cytosine deaminase (CD) enzyme, which can then convert the antibiotic flucytosine into the potent anti-cancer drug 5-FU, inside the cancer cells. 
To be eligible for the clinical trial, patients must be at 18 years to 80 years old and be considering surgery to remove a single high grade glioma tumor that has recurred or progressed following surgery, radiation and chemotherapy with temozolomoide..
In addition to JFK, this clinical trial is also being conducted at other leading neurooncology centers in the United States.
JFK is now screening patients to participate in this clinical trial. Patients and referring physicians can call the study coordinator, Charles Porbeni, at 732-321-7000 x 68897 for further information.
The JFK Brain Tumor Center was established in 1997.  This center brought together experts with extensive training from all over the country to diagnose and treat patients with tumors involving the central nervous system.  These tumors may arise from the brain or spinal cord, or may spread to these areas from somewhere else in the body (for example, the lung, the breast, colon or skin).
This specialized team of physicians has been providing superior, state-of-the-art, comprehensive clinical care and support to patient’s who suffer from tumors of the central nervous system, and their families.  In addition to an advanced program to treat malignant gliomas, we have developed specialized programs to treat skull-based tumors (meningioma, acoustic neuroma, pituitary tumors), spinal tumors, and well as metastatic disease to the central nervous system. In addition, we have a clinical trials team to help patients navigate through the novel therapies available to them.
Overall the JFK Brain Tumor Center is a place where every patient gets state-of-the-art care by a specialized team of physicians, nurses, and other personal all centralized at a single facility.


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