A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors

• Status: Terminated
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MultiCare Health System Research Institute
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

• Clinically documented primary brain tumor for which surgical resection is indicated.

• Age 18 years and older.

• ECOG Performance status less than or equal to 2.

• Laboratory values as follows:

Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.

-Ability to provide informed consent or consent from a Legally Authorized Representative.

Exclusion Criteria:

• Receipt of an investigational agent within 30 days.

• Allergy to ALA or similar compounds.

• Personal or family history of porphyria.

• Uncontrolled intercurrent illness.

• Inability to comply with the protocol.

• Pregnancy, breastfeeding.