NCT01502605

Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Astrocytoma
• Glioma

Interventions

Type	Name	Description
DRUG	5-Aminolevulinic Acid	A one time, single-dose administration of ALA is planned 4 hours pre-operatively the day of surgery. ALA will be mixed in the minimum volume of sterile water or juice immediately before use and given as a single oral bolus. Once ALA has been administered, patients will be kept in subdued lighting away from sunlight.

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-05-01
• Completion: 2016-06-01
• First posted: 2011-12-30
• Last updated: 2017-01-05

Locations

2 sites across 1 country: United States