Monday, April 23, 2012
Hoag Participating in Clinical Trial for Aggressive Brain Cancer
Brain Cancer Vaccine for Local Brain Cancer Patients now available as a
research option in Orange County
NEWPORT BEACH, CA – Hoag Memorial Hospital Presbyterian today announced
that itsNeurosciences Institute is the first Orange County-based center
to begin enrolling patients in a new late-stageclinical 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.
TheDCVax®-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 master immune cells
drawn from the patient’s own blood, and biomarkers from the patient’s
own tumor tissue which together may stimulate a specific immune response
and may cause an extension of the time until the brain cancer recurs,
and extension of survival.
“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 priorsmall 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. All
patients will receive standard of care. Approximately 160 patients will
receive the DCVax®-L treatment, and 80 patients will receive a placebo
(an inactive substance), in addition to the standard of care. 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 initialbrain tumor surgery? in order to consent to the collection
of brain tumor tissue for manufacture of their personalized vaccine.
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.
For more information on the DC-Vax®- Brain for Glioblastoma (GBM)
clinical trial,click here.
About Hoag Neurosciences Institute (HNI)
Hoag Neurosciences Institute (
hoag.org/neurosciences) coordinates clinical neuroscience specialists, dedicated facilities and
the latest technology to provide individualized patient management under
the following programs:Memory and Cognitive Disorders,Brain Tumors,Stroke,Epilepsy,Pain,Movement
Disorders, and Neurobehavioral Disorders. HNI also houses the Multiple
Sclerosis, Voice and Swallowing, and Sleep Centers and is becoming a regional
referral center for all brain and spinal disorders.