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

Inclusion Criteria:

1. Presumptive diagnosis of high grade glioma based on imaging studies, or will have
recurrent high-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.