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

Glioma Clinical Trial

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

Status Terminated

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Astrocytoma
• Glioma

• NCT number: NCT01502605
• Study type: Interventional
• Source: Sidney Kimmel Comprehensive Cancer Center
• Status: Terminated
• Phase: Phase 1
• Start date: September 2012
• Completion date: June 2016