A Study of the Specificity and Sensitivity of 5- Aminolevulinic Acid (ALA) Fluorescence in Malignant Brain Tumors
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
Extent of resection is a very important prognostic factor affecting survival in individuals
diagnosed with a malignant glioma. However, the infiltrative nature of the malignant glioma
tumor cells produces indistinct borders between normal and malignant tissues, and the lack of
easily identifiable tumor margins confounds attempts at total resection. The investigators
propose to identify the borders of malignant gliomas intraoperatively using oral
5-aminolevulinic Acid (5-ALA) which results in fluorescence of the malignant cells and
thereby provide an opportunity for more complete tumor resection.
When exogenous 5-ALA is provided at increased concentration the tumor cells will become
fluorescent under ultraviolet light. This feature identifies the tumor cells intraoperatively
and facilitates complete resection.
Data collection will include measurement of dose-limiting toxicity, tumor fluorescence, and
tumor density. Data analysis will evaluate toxicity, sensitivity, and specificity of 5-ALA.
Time-to-progression, one year survival rate and total survival will be measured as a function
of the extent of resection. (Details below in Detailed Description.)
Following completion of the phase 1 portion of this trial, an additional 15 subjects will be
entered at the recommended phase 2 dose level in order to further define the above parameters
at the recommended phase 2 dose level.