Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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:

1. To determine the impact of the dose of 5-ALA in improving volumetric extent of resection in patients with recurrent high grade gliomas

2. To determine the impact of the dose of 5-ALA in improving overall survival of recurrent high grade glioma patients

3. To determine the impact of the dose of 5-ALA in improving progression-free survival of recurrent high grade glioma patients

4. 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. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT02119338
Study type Interventional
Source St. Joseph's Hospital and Medical Center, Phoenix
Contact Nader Sanai, MD
Phone 602-406-3770
Email Nader.Sanai@bnaneuro.net
Status Recruiting
Phase N/A
Start date February 2014
Completion date September 2017

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04539574 - An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors N/A
Enrolling by invitation NCT04461002 - Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Completed NCT03242824 - The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma Phase 2
Recruiting NCT04186832 - Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy N/A
Completed NCT00424554 - Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed) Phase 2
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT02805179 - A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma Phase 2
Terminated NCT04556929 - Enhanced Detection in Glioma Excision N/A
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Recruiting NCT06043232 - MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
Not yet recruiting NCT06043765 - Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training N/A
Not yet recruiting NCT05025969 - Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
Completed NCT02978261 - Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas Phase 1
Terminated NCT01502605 - Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas Phase 1
Completed NCT01836536 - Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients N/A
Completed NCT01479686 - iMRI Guided Resection in Cerebral Glioma Surgery Phase 3
Completed NCT01212731 - Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
Terminated NCT01044966 - A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma Phase 1/Phase 2