Analysis of phase 2 trial shows potential increase in survival for glioblastoma patients who received vaccine compared to standard of care; Study results support randomized NCI sponsored trial
CHICAGO, Dec. 16, 2013 /PRNewswire-USNewswire/ -- Patients with recurrent glioblastoma multiforme (GBM) treated with an experimental vaccine made from the patient's own resected tumor tissue showed an improved survival compared with historical patients who received the standard of care alone, according to an analysis of a phase 2 trial of this vaccine that was recently published in the journal Neuro-Oncology and accompanied by an editorial highlighting the importance of the trial.
A GBM took the life of former Senator Edward Kennedy in 2009. The most aggressive form of primary brain tumor, GBM tumors are often resistant to standard therapies and median survival is approximately three to nine months for a recurrent tumor.
"We are talking about fast-growing tumors that invade normal brain tissue and are very difficult to treat," said Orin Bloch, MD, a neurosurgeon at Northwestern Memorial Hospital and lead author of the study. "These tumors occur in up to 23,000 Americans annually, and are typically treated with surgical resection of the tumor followed by chemotherapy and radiation treatment."
This phase 2 trial enrolled 41 adult patients with recurrent tumors between 2007 and 2011. Each patient received an average of six doses of the HSPPC-96 vaccine. Following treatment, 90 percent of patients were alive at six months and 30 percent were alive after one year. Further study will be needed to see if this vaccine could potentially be approved to treat recurrent brain tumors. Currently there are only a few approved therapeutic cancer vaccines, none of which are approved for the treatment of GBM.
While new findings continue to extend the lives of patients with glioblastoma, for the moment, it remains one of the most dreaded diagnoses because despite treatment, GBMs almost always come back, said Bloch.
"The grim prognosis is exactly why new research is important," said Bloch, who is an assistant professor of neurological surgery at the Northwestern Feinberg School of Medicine. "GBMs have been around for a long time, and still outcomes are poor. With studies such as this one, I believe we can change that."
The vaccine, HSPPC-96, is produced individually for each patient using that patient's own resected tumor tissue. Following the patient's surgery, the tumor is sent to the vaccine production facility at Agenus Inc., where the HSPPC-96 vaccine is created. The vaccine is unique to the individual participant and is engineered to trigger an immune system response to kill tumor cells that may remain following surgery.
Northwestern Medicine® researchers are currently conducting the next phase of this research, a randomized phase II trial which will investigate if the HSPPC-96 vaccine is safe and more effective when given with Avastin (bevacizumab). Avastin is a drug that is known to shrink brain tumors and is a standard therapy for recurrent GBM.
"When it comes to brain tumor research, I picture our Northwestern Medicine team climbing a mountain and with every new discovery that shows the potential to prolong survival, we are establishing a new base camp," said Andrew Parsa, MD, PhD, corresponding author of the study and chair of neurological surgery at Northwestern Memorial and the Michael J. Marchese Professor and chair of the department of neurological surgery at the Feinberg School. "Someday, thanks to studies like this one, we'll get to the top of the mountain and convert this particular cancer into a chronic disease – something that patients can live with, controlled by medication."
The study, which is chaired by Parsa, is the largest randomized brain tumor vaccine trial ever funded by the National Cancer Institute (NCI). The study is sponsored by the Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative group of the NCI.
Bloch and Parsa are members of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and part of the Northwestern Brain Tumor Institute.
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About Northwestern Memorial Hospital
Northwestern Memorial is one of the country's premier academic medical center hospitals and is the primary teaching hospital of the Northwestern University Feinberg School of Medicine. Along with its Prentice Women's Hospital and Stone Institute of Psychiatry, the hospital has 1,705 affiliated physicians and 6,769 employees. Northwestern Memorial is recognized for providing exemplary patient care and state-of-the art advancements in the areas of cardiovascular care; women's health; oncology; neurology and neurosurgery; solid organ and soft tissue transplants and orthopaedics.
Northwestern Memorial has nursing Magnet Status, the nation's highest recognition for patient care and nursing excellence. Northwestern Memorial ranks 6th in the nation in the U.S. News & World Report 2013-14 Honor Roll of America's Best Hospitals. The hospital is recognized in 14 of 16 clinical specialties rated by U.S. News and is No. 1 in Illinois and Chicago in U.S. News' 2013-14 state and metro rankings, respectively. For 14 years running, Northwestern Memorial has been rated among the "100 Best Companies for Working Mothers" guide by Working Mother magazine. The hospital is a recipient of the prestigious National Quality Health Care Award and has been chosen by Chicagoans as the Consumer Choice according to the National Research Corporation's annual survey for 15 consecutive years.
About the Lurie Cancer Center
The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, one of only two National Cancer Institute-designated Comprehensive Cancer Centers in Illinois, is committed to being a national leader in the battle to overcome cancer. Learn more about the Lurie Cancer Center's patient care, services and programs, research and education, clinical trials, and faculty at cancer.northwestern.edu.
SOURCE Northwestern Medicine