A Phase 1 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

NCT01148966 Phase 1 TERMINATED

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

Details

Lead sponsor	University of Washington
Phase	Phase 1
Status	TERMINATED
Enrolment	6
Start date	2010-06

Conditions

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Oligodendroglioma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Mixed Glioma
• Recurrent Adult Brain Tumor

Interventions

• aminolevulinic acid
• laboratory biomarker analysis
• therapeutic conventional surgery

Primary outcomes

• Establishment of a safe dose for oral ALA administration — For 30 days post-aminolevulinic acid dose
  Using National Cancer Institute (NCI) Common Toxicity Criteria to quantify toxicity following ALA administration. We will use descriptive statistics to analyze the safety data, based on NCI toxicity criteria.
• Determination of which of 3 ALA doses provide optimal discrimination between normal and malignant tissue intraoperatively — During surgery and from samples collected during surgery
  The results from three methods will be used collectively to determine whether or not it is prudent, safe and justified to proceed with 12 more patients using the highest dose tolerated without undue toxicity. The results from these three methods, both surgical fluorescence rating and neuropathologist ratings of fluorescence and presence, or absence, of tumor will be compared using a correlation coefficient.

Countries

United States