Newport Beach, CA (PressExposure) April 24, 2012 -- Hoag Memorial Hospital Presbyterian today announced that its Neurosciences Institute is the first Orange County-based center to begin enrolling patients in a new late-stage clinical trial for an aggressive form of brain cancer: Glioblastoma multiforme (GBM).
Led locally by Hoag and Christopher Duma, MD, FACS, Program Director of Hoag Neurosciences Institute Brain Tumor Program, the FDA-authorized, Phase II trial is sponsored by Northwest Biotherapeutics.
The DCVax®-L personalized cancer immune therapy is an experimental therapeutic "cancer vaccine" which has been under development by Northwest Biotherapeutics for a decade. (In contrast to a "preventive vaccine", a "therapeutic vaccine" is an immune treatment administered to treat a disease that a patient already has, and is intended to help the patient's own immune system to attack the cancer). The purpose of this clinical study is to determine if DCVax®-L can cause an immune response against a patient's GBM cancer cells, and can slow the growth and recurrence of GBM to extend overall survival. This investigational, personalized vaccine is made from the patient's own blood and tumor tissue, which together may stimulate a specific immune response and may cause the brain cancer to stop growing, or to shrink.
"At Hoag, we are always looking for new advanced treatment options for the brain tumor patients in our community," said Dr. Duma.
Hoag is one of a select number of centers nationally currently enrolling in phase II of the trial. In prior small clinical trials, the patients who received DCVax®-L showed a median survival of approximately 3 years, as compared to the median survival of 14.6 months seen in patients who received today's standard of care (surgery, radiation and chemotherapy). The current study is for newly diagnosed patients and is randomized. Approximately 160 patients will receive the DCVax®-L treatment, and 80 patients will receive a placebo (an inactive substance). If a patient's condition in the placebo group worsens, they will be given the option to receive the DCVax® L treatment.
Key to this study is that potential GBM patients must be identified prior to their initial brain tumor surgery in order to consent to the collection of brain tumor tissue for vaccine development.
Brain cancer is diagnosed in about 200,000 patients per year with approximately 40,000 being primary brain cancer. Approximately 60% of primary brain cancers are diagnosed as astrocytoma of which there are four forms, grade I through IV. Glioblastoma multiforme (GBM) is the most aggressive and lethal form of astrocytoma and is classified as grade IV. There are currently few treatment options that significantly influence disease outcome for GBM patients, and a typical survival rate for the disease is 14.6 months.
GBM is a fast-growing tumor that occurs in the central nervous system and can seriously impair brain function. This type of tumor most often occurs in adults between age 45 and 70. Symptoms can include headaches, seizures, difficulty learning or comprehending information, personality changes or paralysis.
About Hoag Memorial Hospital Presbyterian
Hoag is a not-for-profit regional healthcare delivery network that has served in Orange County, California since 1952. Hoag treats nearly 30,000 inpatients and 350,000 outpatients annually and consists of two acute-care hospitals, seven health centers and five urgent care centers. Hoag Hospital Newport Beach, 498 beds, and Hoag Hospital Irvine, 84 beds, are designated Magnet hospitals by the American Nurses Credentialing Center (ANCC). Hoag offers a comprehensive blend of health care services that include five institutes providing specialized services in the following areas: cancer, heart and vascular, neurosciences, women's health and orthopedics through Hoag's affiliate Hoag Orthopedic Institute, which includes a 72-bed single-specialty hospital and two advanced ambulatory surgery centers. Hoag has been named one of the Best Regional Hospitals in the U.S. News & World Report Metro Edition. National Research Corporation has endorsed Hoag as Orange County's most preferred hospital for the past 15 consecutive years and for an unprecedented 16 years, residents of Orange County have chosen Hoag as the county's best hospital in a local newspaper survey. Visit http://www.hoag.org.