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

Inclusion Criteria:

- Patients must have clinically documented primary brain tumor for which resection is
clinically indicated. The anticipated histology at resection should include:
Anaplastic astrocytoma, Astrocytoma, Brain stem glioma, Ependymoma, Glioblastoma,
Glioblastoma multiforme, Gliosarcoma, oligodendroglioma, Medulloblastoma, Mixed
astrocytoma-ependymoma

- Patients may have prior therapy

- 18 years of age

- Male or Female

- Life expectancy is not a consideration for protocol entry

- Patients must have normal organ and marrow function as defined below: Leukocytes
>3,000/mL, Absolute neutrophil count >1,500/mL, Platelets >100,000/mL, 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

- Confirmation of Glial Tumor

- Gross total resection is the aim of surgery

- 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 a written informed consent.

Exclusion Criteria:

- Non-Glial tumor i.e. tumor abscess, metastasis, lymphoma, vasculitis

- Tumor with perforating vessels

- Tumor involves critical fiber tracks

- Use of the microsurgical tool monopolar loop

- Subject has preexisting severe deficits concerning language or motor function not
resolved with steroids

- Performance Status of less than 60

- Prior therapy is not an exclusion criterion

- Patients may not be receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to aminolevulinic acid (ALA)

- Personal or family history of porphorias

- 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