Terry C. Burns, M.D., Ph.D.

The purpose of this study is to evaluate the safety and effectiveness of using Exablate Model 4000 Type-2.0/2.1 in adults with Glioblastoma brain tumors to increase temporarily the permeability of the blood brain barrier, allowing increased passage of circulating free DNA (cfDNA) for sampling and analysis.

The purpose of this study is to help generate a repository of Cerebrospinal  Fluid (CSF) samples relevant to neuro-oncology research that may facilitate the identification of biomarkers that are predictive of disease burden, therapeutic susceptibility or response to therapy. This protocol will also provide a vehicle for CSF access for patients or providers wishing to generate or evaluate individualized biomarkers as part of other research or individualized therapy protocols.

The purpose of this study is to determine the impact of focused ultrasound (FUS) on the composition of the tumor extracellular microenvironment.

Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated tumor surgery in order to facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of exploratory and future tumor biomarkers for individualized monitoring.

The purpose of this study is to evaluate the safety and feasibility of surgical resection for pre-recurrent brain tumors. Eligible patients with surgically accessible latent tumors desiring surgical resection will be enrolled to prospectively track short- and long-term outcomes. Safety will be evaluated by quantifying rates of surgical morbidity as compared to patients undergoing RT after surgery, or no surgery for similar latent disease. Variables evaluated will include postoperative complications including death within 30 days, wound infection, length of hospital stay, and readmission rates.

The purpose of this study is to determine the feasibility of serial cerebrospinal fluid (CSF) assessments to evaluate the pharmacodynamic impact of agents targeting radiation-induced biology administered following completion of brain radiation.

Magnetic resonance spectroscopy is a feasible technique within brain tumor patients to detect metabolic differences between tumor and brain for metabolites indicative of the Warburg effect (lactate) and neural health (NAA and glutamate). Magnetic resonance spectroscopy is a feasible technique within brain tumor patients to detect metabolic differences between tumor and brain for metabolites indicative of the Warburg effect (lactate) and neural health (NAA and glutamate).

The primary objectives of the Dose Escalation (Part 1a and Part 1b) are to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after a single treatment of SONALA-001 in combination with MRgFUS in recurrent or progressive GBM (rGBM), and to characterize the safety, dose limiting toxicities (DLTs) and the recommended phase 2 schedule (RP2S) for future study after two and three treatments of SONALA-001 in combination with MRgFUS in recurrent or progressive GBM (rGBM).

The primary objectives of the Expansion (Part 2) are to evaluate preliminary efficacy (progression-free survival [PFS] rate at 6 months) of the RP2S of ALA SDT treatments by modified response assessment in neuro-oncology (mRANO) in approximately 30 patients with rGBM, and to further characterize safety of the RP2S of ALA SDT.

The purpose of this study is to determine how polyamine depletion impacts extracellular intratumoral guanidinoacetate abundance.

In addition: to determine the impact of polyamine depletion on polyamine abundance and the global extracellular metabolome within live human gliomas, in situ; to assess the feasibility of longitudinal microdialysis for combined pharmacokinetic and pharmacodynamic analysis within live human gliomas in situ in the postoperative setting; to assess the CNS pharmacokinetics of DFMO and AMXT 1501; to assess the short-term safety of study drugs in patients with high-grade gliomas.

The purpose of this study is to establish a prospective repository of detailed patient-specific information regarding the structure and function of human brain tissue impacted by disease and therapeutic interventions, detailing the neurologic and cognitive performance during the course of disease management.

The purpose of this study is to determine the feasibility of placing Ommaya reservoirs at the time of biopsy to enable longitudinal CSF monitoring.