5-ALA in Recurrent Glioma
The investigators propose a single-center, non-randomized, single-arm study at the Barrow Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. This will be done using three cohorts in dose escalation. The investigators' hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result in less false positive fluorescence.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Barrow ALA Trial for Recurrent Gliomas|
- Presence of fluorescence in tumor tissue compared to tissue with treatment effect. [ Time Frame: day of surgery-1 day ] [ Designated as safety issue: No ]Correlation of fluorescence with pathological findings
- Extent of resection [ Time Frame: time within 48 hours post operative ] [ Designated as safety issue: No ]A postoperative MRI with contrast will be acquired within 48 hours of surgery. Volumetric analysis of contract T1-weighted images (for low grade gliomas) will be compared to the preoperative sequences to calculate the volume of residual disease. Slice-by-slice assessment of pre- and postoperative tumor volume will be quantified by sequentially measuring the area of tumor on each slice and then integrating the combined measurements. This methodology has been previously reported (Sanai et al., Journal of Neurosurgery, 2010; Sanai et al, The New England Journal of Medicine, 2008)
- Progression-free survival rate at 6 months [ Time Frame: time from date of surgery to 6 months post surgery ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: time from date of surgery to date of death from any cause, assessed up to 100 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: 5-ala preoperatively
A dose of 5-ala will be taken by mouth approximately 3 hours before going to surgery.
dose of 5-ala will be taken as either 5 mg/kg, 10 mg/kg, or 20 mg/kg approximately 3 hours before going to surgery.
The goal is to determine the dose of 5-ALA which promotes the lowest volume of residual disease after resection of recurrent high grade glioma without compromising the demarcation between recurrent high grade glioma and postoperative bed normal tissue.
- To determine the impact of the dose of 5-ALA in improving volumetric extent of resection in patients with recurrent high grade gliomas
- To determine the impact of the dose of 5-ALA in improving overall survival of recurrent high grade glioma patients
- To determine the impact of the dose of 5-ALA in improving progression-free survival of recurrent high grade glioma patients
- To determine the impact of the dose of 5-ALA on the neurological morbidity of recurrent high grade glioma patients.
Patients with presumed recurrent glioma will be entered into the trial. Those with recurrent disease will receive study drug (5-ALA) in one of three dose-escalated cohorts (5 mg/kg; 10 mg/kg; 20 mg/kg). Intraoperatively, patients will undergo resection with combined fluorescence microscopy and confocal microscopy. Resected tissue specimens corresponding to the presence of fluorescence will be sent to pathology for examination. Postoperatively, patients will have an MRI with and without contrast within 48 hours of surgery. Subsequent analysis of each patient will include assessment of the primary endpoint (volume of residual disease) by volumetrically quantifying the tumor before and after surgery using T1-weighted contrast-enhancement. Similarly, volumetric extent of resection will also be measured.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02119338
|Contact: Nader Sanai, MD||602-406-3770||Nader.Sanai@bnaneuro.net|
|Contact: Norissa Honea, PhD, RN||602-406-6267||Norissa.Honea@dignityhealth.org|
|United States, Arizona|
|Barrow Neurological Institute at St. Joseph's Hospital and Medical Center||Recruiting|
|Phoenix, Arizona, United States, 85013|
|Principal Investigator:||Nader Sanai, MD||Barrow Neurosurgical Associates|