Aminolevulinic Acid Hydrochloride in Visualizing Tumors in Patients with Newly Diagnosed or Recurrent Malignant Gliomas Undergoing Surgery

Inclusion Criteria

• Subjects must have a clinically documented primary brain tumor for which resection is clinically indicated; individuals with suspected newly diagnosed or recurrent malignant gliomas will be considered eligible for the study; the anticipated histology at resection should include: anaplastic astrocytoma (10002224), anaplastic ependymoma, anaplastic oligodendroglioma, astrocytoma malignant not otherwise specified (NOS) (10003572), glioblastoma (10018336), glioblastoma multiforme (10018337), or gliosarcoma (10018340)
• Prior therapy is not a consideration for protocol entry and prior therapy is not an exclusion criteria
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Life expectancy is not a consideration for protocol entry
• Leukocytes >= 3,000/mL
• Platelets >= 100,000/mL
• Total bilirubin below upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
• Creatinine below upper limit of normal 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; a pregnancy test will be performed for all women of childbearing ability prior to surgery; women who are pregnant will be excluded from the trial
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Tumors of or involving the midline, basal ganglia, or brain stem as assessed by MRI
• Subjects may not be receiving any experimental therapies
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ALA; patients should refrain from use of other potential phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 72 h
• 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 from this study; breastfeeding should be discontinued if the mother is treated with ALA
• Women who are pregnant will be excluded from the trial
• Prior history of gastrointestinal (GI) perforation, diverticulitis, and/or peptic ulcer disease