Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
Status:
Terminated
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This research is being done to study the safety and utility of 5-aminolevulinic acid (5-ALA)
(also known as Gliolan) for identifying brain tumor tissue during surgery. The goal of this
study is to determine if 5-ALA can differentiate between tumor and normal brain tissue.
Sometimes, during brain surgery, the removal of tumor tissue can be difficult because the
tumor can look like normal brain tissue. Studies in other countries have shown that in some
brain tumors, 5-ALA can make the tumors appear brighter under ultraviolet light. This may
make it easier for doctors to remove as much tumor as safely as possible from your brain.
This study also hopes to see if 5-ALA can find different cell populations within the tumor
that is removed and allow the researchers to better understand brain tumors.
The purpose of this study is to:
- Find out how well 5-ALA can separate normal brain tissue from tumor tissues AND to see
how well 5-ALA can find different cell populations within brain tumors
- Identify the amount of 5-ALA that should be taken before surgery to make the tumors glow
under ultraviolet light
- Make sure the 5-ALA identifies tumor and not normal brain
- Make sure 5-ALA does not cause any side effects
Phase:
Phase 1
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins