A Phase 1 and 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. Anticipated histology at resection should include:anaplastic
astrocytoma, astrocytoma malignant NOS,brain stem glioma, ependymoma malignant,
glioblastoma, glioblastoma multiforme, gliosarcoma, malignant oligodendroglioma,
medulloblastoma, mixed astrocytoma-ependymoma

- prior therapy is not a consideration in protocol entry

- age unrestricted

- ECOG performance status<2(Karnofsky>60%,)

- 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

- 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.

- 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:

- 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 adic (ALA)

- personal or family history of porphyrias

- 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

- pregnant women are excluded, breastfeeding should be discontinued if mother is
treated with aminolevulinic acid.