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A Phase 1 and 2 Study of 5-Aminolevulinic Acid (5ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

IRB Number

12-135

ClinicalTrials.gov Identifier

NCT01403311

Trial Status

Open for Enrollment
Phase 2

Why is this study being done?

The purpose of this study is to determine the safety and benefit of using 5-aminolevulinic acid (5-ALA) to help identify your tumor during surgery. When your doctors remove the tumor from your brain, it is important that they remove as much of the tumor as possible and not remove parts of the healthy brain tissue. Sometimes this can be difficult because the tumor can look like healthy brain tissue.

Who is eligible to participate?

Patients undergoing surgery for malignant glial tumors of the brain.

What is involved?

About 2-3 hours before you go to the operating room, you will be asked to drink a small amount of liquid containing the study drug, 5-ALA. You will have the following tests and procedures which are standard whether or not you enroll in this study: surgery, blood tests, visits with your doctor, and brain scans (MRI brain with gadolinium) A calendar showing the times you will have different tests is shown below. The tests and exams indicated in the grey areas are estimates of times and procedures that normally occur during the follow-up period after removal of a brain tumor, but vary with each individual according to their needs. The particular tests and procedures and the date when they should be done will be determined by you and an oncologist, as needed. Baseline evaluations are to be conducted within two weeks prior to start of protocol therapy. Scans and x-rays must be done within one week prior to the start of therapy Adverse events will be recorded up to 30 days following surgery.Except for taking 5-ALA before surgery, all procedures and hospital visits are the same as those that would be done if you were not in this study.

How long is the study?

Approximately 2 years

Who can I contact for additional information?

Barbara Cray Lokaitis 217-545-9737

Who is the Principal Investigator of this study?

Jeffrey Cozzens, MD

Where is the trial located?

Springfield, Illinois