A PHASE 1 AND 2 STUDY OF 5-AMINOLEVULINIC ACID (5-ALA) TO ENHANCE VISUALIZATION AND RESECTION OF MALIGNANT GLIAL TUMORS OF THE BRAIN
The purpose of this study is to determine the safety and benefit of using 5-aminolevulinic acid (5-ALA) to help identify your tumor during surgery. When your doctors remove the tumor from your brain, it is important that they remove as much of the tumor as possible and not remove parts of the healthy brain tissue. Sometimes this can be difficult because the tumor can look like healthy brain tissue. In some brain tumors 5-ALA can make the tumors glow red under deep blue light (a "black light"). 5-ALA is a naturally occurring substance that is found in all living things, including humans, and is a necessary part of basic life functions.
When an excess of 5-ALA is given before surgery, this drug may make it easier for your doctor to see the difference between tumor and healthy brain. The use of 5-ALA in this study is investigational because it is not approved by the FDA for use during brain surgery. However, it is approved by the FDA for use in treating skin diseases.
The purpose of this study is to:
- identify the amount of 5-ALA that should be taken before surgery to make the tumors glow red;
- determine if 5-ALA glow (fluorescence) is specific for brain tumor and not healthy brain; and
- monitor any side effects from 5-ALA.