WCI1999-11: A Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas

Inclusion Criteria:

- Patients 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. Sixty (60) newly
diagnosed and recurrent malignant gliomas will be enrolled in this study. The
anticipated histology at resection should include: Anaplastic astrocytoma
(10002224), Anaplastic ependymoma, Anaplastic oligodendroglioma, Astrocytoma
malignant NOS (10003572), Glioblastoma (10018336), Glioblastoma multiforme
(10018337), or Gliosarcoma (10018340).

- Prior therapy is not a consideration in protocol entry.

- Age 18-80.

- ECOG performance status <2 (Karnofsky >60%, see Appendix A).

- Life expectancy is not a consideration for protocol entry.

- Patients must have normal organ and marrow function as defined below:

Leukocytes >3,000/mL Absolute neutrophil count >1,500/mL Platelets >100,000/mL 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.

- The effects of Aminolevulinic Acid (ALA) on the developing human fetus are unknown.
For this reason, 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

Exclusion Criteria:

- Prior therapy is not an exclusion criterion.

- Tumors of or involving the midline, basal ganglia, or brain stem as assessed by MRI

- Patients may not be receiving any experimental therapies.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to aminolevulinic acid (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 porphorias.

- 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 because aminolevulinic
acid (ALA) is of unknown teratogenic or abortifacient effects. Because there is an
unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with aminolevulinic acid (ALA), breastfeeding should be
discontinued if the mother is treated with aminolevulinic acid (ALA)

- Inclusion of Women and Minorities: Both men and women and members of all ethnic
groups are eligible for this trial.