Photo: Administration of the 5-ALA drug causes malignant
brain cells to appear red under fluorescent light.
July 25, 2012
SIU Med School Clinical Trial Attempts to Improve Surgery for Malignant Brain Tumors
Neurosurgeons are using an experimental drug to identify malignant brain tumor tissue using fluorescent light during surgery in a clinical trial at Southern Illinois University School of Medicine’s Division of Neurosurgery and the Center for Clinical Research.
“We are excited about the potential this trial brings,” says principal investigator Dr. Jeffrey Cozzens, professor and chief of SIU’s Division of Neurosurgery. “It is often challenging to completely remove a malignant brain tumor, because it’s difficult to distinguish the tumor from normal brain tissue. Being able to make this distinction and resect the tumor more completely may improve survival rates.”
Participants of this Phase 1 and 2 study will receive 5-Aminolevulinic Acid (5-ALA) by mouth to enhance visualization and potentially resection of malignant glial tumors of the brain.
Gliomas originate in the glial cells, which surround the support nerve cells. Glioma is on the rise in the United States. An estimated 12,000 people die each year from this tumor.
When given at an increased concentration, the 5-ALA drug produces an excess of protoporphorin in the malignant cell, increasing at a rate far greater than normal brain cells. It renders the malignant cells fluorescent red under blue light. This distinguishes the tumor cells from normal cells intraoperatively and assists in complete resection. Currently, eight patients have undergone this procedure and the goal is to have about 33 patients total.
Currently the European Medicines Agency has approved oral 5-ALA for this indication, but it has not yet been approved by the United States Food and Drug Administration. The hope of this trial is to get the U.S. approval.
The American Cancer Society estimates that 23,000 malignant tumors of the brain or spinal cord will be diagnosed in adults this year in the United States. Approximately 13,700 people will die from these malignant tumors. Survival rates vary widely, depending on the type of tumor.
For more information about this trial, call Susan Helm at 217-545-7012.