A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
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|ClinicalTrials.gov Identifier: NCT01351519|
Recruitment Status : Terminated (Limited staff available for enrollment and limited availability of drug)
First Posted : May 11, 2011
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma Glioma Glioblastoma Glioblastoma Multiforme Astrocytoma||Drug: Aminolevulinic Acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
|Experimental: Aminolevulinic Acid (AL)||
Drug: Aminolevulinic Acid
Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.
- Time to disease progression after initial surgery. [ Time Frame: Up to 2 years ]Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
- Complete Resection [ Time Frame: Day 2 ]Determine the percentage of patients with complete resections of contrast-enhancing tumor, compared to historical controls
- Determine the number of subjects with adverse events due to ALA in this dosage and indication. [ Time Frame: Through 45 days ]Subjects will be followed closely for adverse events including biochemical abnormalities through laboratory monitoring and for clinically evident adverse events including possible skin reactions that may occur.
- Overall Survival [ Time Frame: Up to three years ]Determine the overall survival compared to historical controls.
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): NCT01351519
|United States, Washington|
|MultiCare Health System Research Institute|
|Tacoma, Washington, United States, 98405|
|Principal Investigator:||William Morris, MD||MultiCare Health System|
|Study Director:||Richard Shine, PharmD, BCPS||MultiCare Health System Research Institute|