An interventional study of 5-ala in Glioma, sponsored by St. Joseph's Hospital and Medical Center, Phoenix. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-06.
Sponsored by St. Joseph's Hospital and Medical Center, Phoenix · Not applicable, Interventional, and Diagnostic
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.
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.
Sub-goals:
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.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's planned enrollment of 60 is above the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →St. Joseph's Hospital and Medical Center, Phoenix is the lead sponsor of 63 studies on the registry; 11 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
A dose of 5-ala will be taken by mouth approximately 3 hours before going to surgery.
Drug: 5-ala
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.
Also known as: 5-aminolevulinic acid, Levulin(R)
Presence of fluorescence in tumor tissue compared to tissue with treatment effect.
Correlation of fluorescence with pathological findings
Time frame: day of surgery-1 day
Extent of resection
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)
Time frame: time within 48 hours post operative
Progression-free survival rate at 6 months
Time frame: time from date of surgery to 6 months post surgery
Overall survival
Time frame: time from date of surgery to date of death from any cause, assessed up to 100 months
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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St. Joseph's Hospital and Medical Center, Phoenix