This randomized phase II trial studies the best dose of aminolevulinic acid hydrochloride when given before an imaging procedure in finding residual tumor in patients with grade IV malignant gliomas who are undergoing surgery. Imaging procedures that use aminolevulinic acid hydrochloride may help find and diagnose residual tumor in patients with grade IV malignant gliomas who are undergoing surgery to remove the tumor.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00752323.
PRIMARY OBJECTIVES:
I. Assess 2 doses of 5-ALA (aminolevulinic acid hydrochloride), 10 kg/mg and 20 kg/mg, to determine the optimum ALA (aminolevulinic acid hydrochloride) dose in terms of both sensitivity and specificity for residual tumor.
SECONDARY OBJECTIVES:
I. Assess the correlation between the recorded in vivo qualitative assessment of fluorescence signal from the neurosurgeon with the post-surgical (i.e., ex vivo) absolute protoporphyrin IX (PpIX) concentration detected both intraoperatively and in ex vivo tissue biopsies.
TERTIARY OBJECTIVES:
I. To determine the association between the presence of fluorescence in the surgical cavity and the post-operative image enhancement on magnetic resonance imaging (MRI).
OUTLINE: Patients are randomized to 1 of 2 dose levels.
ARM I (de novo): Patients with newly diagnosed disease receive lower dose aminolevulinic acid hydrochloride orally (PO) at 3 hours before the midpoint of surgery.
ARM II (de novo): Patients with newly diagnosed disease receive higher dose aminolevulinic acid hydrochloride PO at 3 hours before the midpoint of surgery.
ARM III (recurrent): Patients with recurrent disease receive lower dose aminolevulinic acid hydrochloride PO at 3 hours before the midpoint of surgery.
ARM IV (recurrent): Patients with recurrent disease receive higher dose aminolevulinic acid hydrochloride PO at 3 hours before the midpoint of surgery.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorAndrew Edward Sloan
