A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.
Drug: Aminolevulinic Acid
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain|
- Time to disease progression after initial surgery. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Determine time-to-progression compared to that in comparable cases performed without the aid of ALA.
- Complete Resection [ Time Frame: Day 2 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Determine the overall survival compared to historical controls.
|Study Start Date:||May 2011|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Drug: Aminolevulinic Acid
- 5-Aminolevulinic Acid
This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.
|Contact: Diane Miller, RN, MSNfirstname.lastname@example.org|
|Contact: Christine Goetz, BSemail@example.com|
|United States, Washington|
|MultiCare Health System Research Institute||Recruiting|
|Tacoma, Washington, United States, 98405|
|Contact: Richard Shine, PharmD, BCPS 253-403-7250 firstname.lastname@example.org|
|Principal Investigator: William Morris, MD|
|Sub-Investigator: Peter Brown, MD|
|Sub-Investigator: Anthony Harris, MD, PhD|
|Principal Investigator:||William Morris, MD||MultiCare Health System|
|Study Director:||Richard Shine, PharmD, BCPS||MultiCare Health System Research Institute|