Cancer researchers nationwide are investigating whether a vaccine generated from a patientís own white blood cells can boost the immune system to fight off brain cancer recurrence.
Led locally by UC oncologist Margie Gerena-Lewis, MD, this phase-2 experimental vaccination trial, sponsored by Northwest Biotherapeutics, aims to find a more effective way of treating a certain type of cancerous brain tumor known as glioblastoma multiforme, or GBM.
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.
Gerena-Lewis says GBM is very aggressive and difficult to treat.
"Glioblastoma multiforme is considered treatable but not curable with current modalities. It tends to come back after surgery, radiation and chemotherapy," says Gerena-Lewis, an assistant professor at UC and medical oncologist at the UC Barrett Cancer Center at University Hospital.
According to the American Cancer Society, nearly 22,000 American adults will be diagnosed with a malignant brain tumor in 2008. The five-year survival rate for patients with high-grade GBM is just 2 percent.
UC is looking for 30 patients, ages 18 to 70, with a newly diagnosed GBM that is surgically accessible and could be totally, or almost entirely removed to participate in this multicenter, placebo-controlled clinical trial. About 270 patients are expected to enroll in the study nationwide.
"The fresh tumor tissue must be processed the day of the surgery in order to be able to develop the vaccine," explains Gerena-Lewis. "Our goal is to stimulate the bodyís immune system to recognize and fight the tumor cells."
After the tumor is surgically removed, the fresh tumor tissue will be immediately sent to a laboratory where it is processed (tumor lysate).
At a later time, a specific type of white blood cell (monocyte) will be harvested from the patient through a process called leukapheresis to be done at Hoxworth Blood Center and shipped the same day to an outside laboratory to develop the dendritic cells. These cells will be combined with the tumor lysate to develop a customized vaccineó called DCVAX-Brain.
"This trial represents the future of cancer therapy: personalized medicine," explains Gerena-Lewis. "We are using the patientís own cells to create a customized vaccine that can trigger the immune system to recognize and destroy cancer cells."
Patients will be randomized into one of two treatment arms to receive either the DCVAX-Brain treatment or a placebo. All patients will receive combined chemotherapy and radiation therapy followed by additional chemotherapy.
Individuals who experience disease progression after the initial combined chemotherapy and radiation will be included in an informational arm of the study and also be eligible to receive the vaccine.
Study participants will receive up to 10 immunizations of DCVAX-Brain or a placebo over the course of three years. Injections are given at set intervals in the upper arm under the skin.
"We are hopeful that vaccine therapy will be the Holy Grail that will lead to a cure for glioblastoma multiforme," says Ronald Warnick, MD, director of the UC Brain Tumor Center. The center is closely affiliated with the Barrett Cancer Center.
This trial is currently open at 10 centers nationwide, and expected to open at many more.
Gerena-Lewis, Warnick and their colleagues have no financial interest in Northwest Biotherapeutics.
Other study co-investigators include John Breneman, MD, radiation oncology; Patricia Carey, MD, transfusion medicine; Ady Kendler, MD, PhD, pathology; Christopher McPherson, MD, neurosurgery; and Apurva Mehta, MD, hematology-oncology.
For trial enrollment information, call Jamie McGuire at (513) 584-2207.
This multidisciplinary clinical research team is affiliated with the UC Brain Tumor Center, a center of excellence within the Neuroscience Institute at UC and University Hospital. It is part of a joint cancer program involving the UC College of Medicine, Cincinnati Childrenís Hospital Medical Center and University Hospital.
The collaborative initiative brings together interdisciplinary research teams of caring scientists and health professionals to research and develop new cures, while providing a continuum of care for children, adults and families with cancer.