Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery

A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.

A one time oral dose of ALA is taken before surgery. The medication makes the tumor visible under ultraviolet light which allow the surgeon to see more of the tumor for a more complete removal.

Patients with primary neoplastic brain tumors (Grades II-IV) will participate in this trial. Each patient will have been evaluated and found to have such a tumor by history and recent imaging studies (MRI) and deemed a surgical candidate based on current neurosurgical standards of care.

Inclusion Criteria:

• Suspected primary brain tumor
• 18 years of age or more
• Normal marrow and organ function
• Eastern Cooperative Group performance status ≤ 2
• Women of childbearing potential must use adequate birth control
• Ability to understand and willingness to sign a written informed consent form
• Life expectancy not a consideration

Exclusion Criteria:

• Receiving any other investigational agents
• History of allergic reactions to ALA
• Personal or family history of porphyrias
• Liver disease in the past year
• Uncontrolled intercurrent illness
• Pregnant or lactating women
• Inability to undergo MRI with contrast