A Study of the Specificity and Sensitivity of 5- Aminolevulinic Acid (ALA) Fluorescence in Malignant Brain Tumors
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|ClinicalTrials.gov Identifier: NCT01128218|
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : September 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasms||Drug: Tumor fluorescence||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 and 2 Study of 5-aminolevulinic Acid (5-ALA) to Enhance Visualisation and Resection of Malignant Glial Tumors of the Brain|
|Actual Study Start Date :||March 2011|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
Experimental: Tumor fluorescence
A single arm in this open-label study where all patients are treated with the study drug - 5-aminolevulinic acid. Areas of the brain that are fluorescent and areas that are not fluorescent are evaluated for presence of tumor cells
Drug: Tumor fluorescence
oral doses in phase 1 study of 10mg/kg, 20 mg/kg, 30 mg/kg, 40 mg/kg and 50 mg/kg
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]Change in the following factors will be continually reviewed between baseline and 6 months: nausea and vomiting; liver function; photo-sensitivity; survival
- Tumor fluorescence intra-operative assessment by neurosurgeon [ Time Frame: baseline ]During surgery, neurosurgeon will assess tumor fluorescence (0 to +++) in three distinct areas of fluorescence (Strong fluorescence, Weak fluorescence, No fluorescence) to determine level of 5-ALA mediated fluorescence.
- Tumor fluorescence intra-operative assessment by neurosurgeon [ Time Frame: 24 months ]During surgery, neurosurgeon will assess tumor fluorescence (0 to +++) in three distinct areas of fluorescence (Strong fluorescence, Weak fluorescence, No fluorescence) to determine level of 5-ALA mediated fluorescence.
- Tumor density determined by post-operative imaging [ Time Frame: baseline ]Tumor density from biopsies obtained by the neurosurgeon will be assessed by neuropathology (Solid tumor, Tumor mixed infiltrating normal brain, No tumor).
- Tumor density determined by post-operative imaging [ Time Frame: 24 months ]Tumor density from biopsies obtained by the neurosurgeon will be assessed by neuropathology (Solid tumor, Tumor mixed infiltrating normal brain, No tumor).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128218
|United States, Illinois|
|Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62702|
|Principal Investigator:||Jeffrey W Cozzens, MD||Southern Illinois University School of Medicine|