Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain
Condition: Glioma
MeSH terms: Glioma; Brain Neoplasms
Intervention: 5-Aminolevuline Acid (ALA)
Intervention description: Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Maximum age: 72 Years
Healthy volunteers: No
Keywords: glioma; high grade glioma, low grade glioma

Summary:

      The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular
      accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On
      imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting
      in the surgeon being better able to visualize and thus able to make a complete, or
      near-complete resection of the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Presumptive diagnosis of high grade or low grade glioma based on imaging studies, or
             will have recurrent high-grade or low grade gliomas that have previously undergone
             diagnosis (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic
             astrocytoma, and glioblastoma multiforme). Both of these groups will be undergoing
             craniotomy for tumor resection.

          2. Patient age 18 to 72 years.

          3. Karnofsky performance of 60% or greater

          4. Patients must have normal organ and marrow function as defined below:

             Leukocytes >3,000/μL Absolute neutrophil count >1,500/μL Platelets >100,000/μL 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.

          5. The effects of Aminolevulinic Acid (ALA) on the developing human fetus are unknown.
             Therefore, 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.

          6. Patient must have the 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 the written informed consent.

        Exclusion Criteria:

          1. Subjects with a history of allergic reactions attributed to compounds of similar
             chemical or biologic composition to aminolevulinic acid (ALA).

          2. Subjects with a history or family history of Porphyrias

          3. Subjects with 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.

          4. Pregnancy.