ATLANTA – A Phase II clinical trial, testing the safety and effectiveness of an investigational new drug (IND) to aid in the surgical removal of malignant brain tumors, will soon get underway at Emory University Hospital Midtown and Winship Cancer Institute of Emory University.
Emory will be the first site in the U.S. to test the European marketed drug, 5-ALA (5-Aminolevulinic Acid), known as Gliolan® in the U.S. 5-ALA has not been approved by the U.S. Food and Drug Administration (FDA) at this time, but is approved for use in Europe, and is being used there.
Costas Hadjipanayis, MD, PhD, with new blue light microscope, which will be used in clinical trial with investigational new drug.
When neurosurgeons remove brain tumors, the goal of the surgery is to remove as much of the tumor as possible without damaging the nearby healthy brain tissue. Sometimes this can be difficult because the tumor can look like normal brain tissue. By better defining the margins of cancerous tissue, researchers believe this will allow for a more complete tumor removal and improved outcomes.
When the study drug is taken orally, 5-ALA is absorbed by malignant gliomas (WHO Grade III and IV brain tumors, including glioblastoma multiforme tumors) and is metabolized to create fluorescent molecules under a blue light microscope. The tumor then glows a violet-red color with the special blue light from the operative microscope, allowing the neurosurgeon to see the full scope of the tumor. Normal brain tissue does not light up red, differentiating the tumor from surrounding normal brain.
“We are excited to launch the use of Gliolan in the U.S. for fluorescence-guided brain tumor removal,” says Costas Hadjipanayis, MD, PhD, assistant professor of neurosurgery, Emory University School of Medicine, and chief of neurosurgery at Emory University Hospital Midtown. “The direct visualization of the tumor will permit more radical resections, allowing patients to move onto medical and radiation therapies that will ultimately provide clinical benefits to the patient.” Hadjipanayis serves as principal investigator of the trial.
The study seeks to enroll 33 people, 23 newly diagnosed malignant brain tumor patients and 10 recurrent malignant brain tumor patients, over a two-year period.
Participants in the trial will be administered oral 5-ALA three to five hours before fluorescence-guided brain surgery to allow for proper absorption. Possible side effects of the drug include nausea or vomiting, a prickling or burning sensation under the skin if exposed to the sun one or two days after taking the IND and abnormalities in liver function in some patients.
“This clinical trial will help to determine if 5-ALA causes any side effects, and if the study drug helps neurosurgeons with better removal of malignant brain tumors,” Hadjipanayis explains.
Following this clinical trial, researchers are planning a multi-center Phase III randomized clinical trial that could lead to potential FDA approval of this agent in the U.S.
For more information, please call 404-778-5770.
The Robert W. Woodruff Health Sciences Center of Emory University is an academic health science and service center focused on missions of teaching, research, health care and public service.
Contacts: Janet Christenbury: 404-727-8599