Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

Inclusion Criteria:

• Age >= 18 years

• Clinical and radiographic evidence suggesting a diagnosis of a diffuse high gradeglioma (HGG), or a prior diagnosis of a diffuse glioma

• Planned subtotal resection or biopsy due to tumor location, size, or other clinicalindication deemed appropriate by the surgeon

• Provide written informed consent for the current study and the Neuro-Oncologybiorepository for archiving of cerebrospinal fluid (CSF) and blood samples collectedon this protocol. Willing to remain in the hospital at Mayo Clinic (Rochester, MN)for three days added to their standard post-operative stay to undergo longitudinalmicrodialysis

• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L without transfusion within 7 dayspreceding the lab assessment (obtained =< 14 days prior to registration)

• Platelet >= 100 x 10^9/L, without transfusion within 7 days preceding the labassessment (obtained =< 14 days prior to registration)

• Hemoglobin >= 9 g/dL, without transfusion support within 7 days preceding the labassessment (obtained =< 14 days prior to registration)

• Activated partial thromboplastin time or partial thromboplastin time (aPTT or PTT) =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (obtained =< 14 days prior to registration)

• Total serum bilirubin =< 1.5 x ULN (obtained =< 14 days prior to registration)

• The patient is clinically euthyroid [Thyroid Stimulating Hormone (TSH)]

• Serum creatinine =< 1.5 x ULN or creatinine clearance >= 60 mL/min/1.73 m^2 forpatients with serum creatinine levels above 1.5 x ULN (obtained =< 14 days prior toregistration)

• Negative serum or urine pregnancy test is required for female subjects ofchildbearing age < 14 days prior to registration

Exclusion Criteria:

• Inappropriate surgical candidates due to current or past medical history oruncontrolled concurrent illness which limits safety of or compliance to studyproceedings

• Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped

• Unable to swallow tablets or who are at risk for impaired absorption of oralmedication. NOTE: This includes but not limited to, refractory vomiting, gastricresection/bypass, and duodenal/jejunal resection

• Known hypersensitivity or allergy to DFMO or AMXT 1501

• Contraindication to MRI or administration of gadolinium