Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain

The drug, 5-aminolevulinic acid (ALA), which leads to intracellular accumulation of
fluorescent porphyrins in gliomas will be used under investigation for identification and
resection of high and low grade gliomas. Surgery will be done using a modified neurosurgical
microscope, with a fluorescent kit that enables switching from the conventional white light
to a violet-blue excitation light for visualization during tumor resection. If deemed safe by
the neurosurgeon, any area of the resection bed determined to be fluorescence-positive for
tumor will be removed with appropriate designation of tissue for histopathological
evaluation. After this resection, additional fluorescence images will be obtained and the
process repeated until the image is negative for tumor. At all times, the decision to resect
will be limited by clinical judgment of safety.

The desire is that a more complete resection will occur due to the surgeon's ability to
better visualize and distinguish between tumor and normal tissue, and thus be able to remove
as much, or most of, the tumorous tissue, resulting in a better outcome for the patient, or
for future patients.

Inclusion Criteria:

1. Presumptive diagnosis of high grade or low grade glioma based on imaging studies, or
will have recurrent high-grade or low grade gliomas that have previously undergone
diagnosis (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic
astrocytoma, and glioblastoma multiforme). Both of these groups will be undergoing
craniotomy for tumor resection.

2. Patient age 18 to 72 years.

3. Karnofsky performance of 60% or greater

4. Patients must have normal organ and marrow function as defined below:

Leukocytes >3,000/μL Absolute neutrophil count >1,500/μL Platelets >100,000/μL Total
bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT) <2.5 X
institutional upper limit of normal Creatinine within normal institutional limits or
Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above
institutional normal.

5. The effects of Aminolevulinic Acid (ALA) on the developing human fetus are unknown.
Therefore, women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
entry and for the duration of study participation.

6. Patient must have the ability to understand and the willingness to sign a written
informed consent document or have a parent or guardian with the ability to understand
and the willingness to sign the written informed consent.

Exclusion Criteria:

1. Subjects with a history of allergic reactions attributed to compounds of similar
chemical or biologic composition to aminolevulinic acid (ALA).

2. Subjects with a history or family history of Porphyrias

3. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements.

4. Pregnancy.