Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
- Patients must have clinically documented primary brain tumor for which resection is
clinically indicated. Radiographic findings should be consistent with high grade
glioma. Intraoperative frozen section should either be: anaplastic astrocytoma (WHO
Grade III astrocytoma) or glioblastoma (WHO Grade IV astrocytoma).
- Patients must be aged greater than 18 years old
- Karnofsky Performance Score > 70 (Appendix)
- Patients must have normal organ and marrow function as defined below:
- Leukocytes > 3,000 /uL
- Absolute neutrophil count > 1,500/uL
- Platelets > 100,000/uL
- Total bilirubin within normal institutional limits
- AST/ALT within normal institutional limits
- Creatinine within normal institutional limits
- Prior craniotomy for resection, deep seated tumors in thalamus and brain stem.
- History of allergic reactions to compounds of similar chemical composition to ALA.
- Personal or family history of porphyrias
- Personal history of hepatitis or other liver diseases.
- Pregnant women are excluded from this study because ALA is of unknown teratogenic
effects. Because there is an unknown but potential risk for adverse events in nursing
infants secondary to treatment of the mother with ALA, breastfeeding should be
discontinued prior to treatment with ALA.
- Inability to undergo magnetic resonance imaging (i.e. those patients with