The study will examine the addition of the vaccine following standard therapy with surgery and chemotherapy in patients with glioblastoma multiforme, a deadly form of brain cancer.
The vaccine, called DCVax-Brain, includes proteins found in patients' tumors and is designed to hit cancer cells containing these proteins.
The study underway at NYU Medical Center is an extension of an earlier phase I trial of the vaccine, made by the Northwest Biotherapeutics, Inc., based in Bothell, Washington.
"We are really excited about the promise of this vaccine. Everything now depends on something in addition to surgery so that these tumors do not recur. A cancer vaccine like this may make a difference in extending life and maintaining a good quality of life," said Patrick J. Kelly, M.D., the chairman of the Department of Neurosurgery and the Joseph Ransohoff Professor of Neurosurgery at NYU School of Medicine.
NYU neuro-oncologist Michael Gruber, M.D. seconded the opinion, saying, "This is a form of individualized therapy. There is a lot of promise with this approach."
A brain cancer vaccine is intended as a kind of immunotherapy, which means that it primes the patient's own immune system to kill proteins found in cancer cells.
The trial will enroll patients 18 to 65 years old with newly diagnosed glioblastoma multiforme brain cancer who will receive standard primary treatment with surgery followed by radiation with concurrent chemotherapy. Enrolled patients will be randomized to receive the standard of care, and others will receive the standard of care and the vaccine.
The vaccine will be made from the tumors and immune cells of each patient. When a patient's tumor is removed during surgery it will be shipped to a laboratory where the tumor cells will be broken up to prepare the first component of the vaccine.
Separately, patients' dendritic cells, a powerful type of immune cell, will be obtained and sent to a laboratory for purification. Dendritic cells may be able to teach the immune system to recognize and destroy cancer cells. The patients' tumor cell material is combined with the dendritic cells to form the vaccine.