Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme

PRIMARY OBJECTIVES:

I. Determine the volume of residual enhancing tumor after a 5-ALA guided resection of a
glioblastoma multiforme (GBM).

II. Determine the volume of tissue removed compared to the measured enhancing tumor evaluated
on a pre-operative MRI.

SECONDARY OBJECTIVES:

I. Evaluate the time to tumor progression. II. Evaluate the overall survival.

OUTLINE:

Patients receive aminolevulinic acid orally (PO) 2-4 hours before surgery.

After completion of study treatment, patients are followed up for 2 weeks.

Inclusion Criteria:

- Patients must have a suspected or biopsy proven newly diagnosed GBM, or a recurrent
GBM or suspected GBM (in patient with pathologically diagnosed prior World Health
Organization [WHO] grade II or III tumor) in a patient undergoing a
clinically-indicated surgery.

- Age >= 18 years of age.

- Eastern Cooperative Oncology Group (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:

- Absolute neutrophil count >= 1,500/uL

- Platelets >= 100,000/uL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT])
=< 2.5 x institutional upper limit of normal

- Creatinine within normal institutional limits; OR

- Creatinine clearance >= 60 mL/min/1.73 m^2 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; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately

- 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 aminolevulinic acid (ALA)

- Current treatment with hypericin (or an extract) or other photosensitizing agents

- Personal or immediate family (parents, siblings, children) 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 from this study; breastfeeding should be discontinued if
the mother is treated with ALA