Adult Glioblastoma Clinical Trial
Official title:
A Phase 1 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain
This phase I trial is studying the side effects and best dose of aminolevulinic acid during surgery in treating patients with malignant brain tumors. Aminolevulinic acid becomes active when it is exposed to a certain kind of light and may help doctors find and remove tumor cells during surgery
PRIMARY OBJECTIVES I. Establish a safe dose for oral ALA administration.
SECONDARY OBJECTIVES I. Determine which of 3 ALA (aminolevulinic acid) doses (10, 20 or 30
mg/kg) provide optimal discrimination between normal and malignant tissue intraoperatively.
II. Determine whether or not the use of ALA (compared to comparable cases performed without
the aid of ALA) leads to a higher rate of gross total resection, as determined by
postoperative MRI scanning within 48 hour of surgery completion.
III. Compare time-to-progression and survival to that in comparable cases performed without
the aid of ALA.
OUTLINE: This is a phase I, dose-escalation study
Patients receive aminolevulinic acid orally (PO) 4 hours before undergoing surgery. After
completion of study treatment, patients are followed up at week 5 and then every 8-12 weeks
for 27 months.
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