Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme
Condition: Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor
MeSH terms: Glioblastoma; Gliosarcoma
Intervention: aminolevulinic acid; therapeutic conventional surgery
Intervention description: Given PO; Undergo surgery
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and performance of an investigational
      agent, known as 5-ALA or Gliolan (aminolevulinic acid), that many be useful to a surgeon for
      visualizing a tumor during surgery. It is also being studied to determine if there are
      differences in what Gliolan shows a surgeon compared to intraoperative magnetic resonance
      imaging (MRI)
    

Eligibility criteria:

        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