PRIMARY OBJECTIVE:~I. Determine how polyamine depletion impacts extracellular guanidinoacetate abundance.~SECONDARY OBJECTIVES:~I. Determine the impact of polyamine depletion on polyamine abundance and the global extracellular metabolome within live human gliomas, in situ.~II. Assess the feasibility of longitudinal microdialysis to evaluate pharmacodynamic responses of in situ gliomas to therapeutic intervention in a post-operative setting.~III. Assess the central nervous system (CNS) pharmacokinetics of eflornithine (DFMO) and AMXT 1501.~IV. Adverse effects of study drugs in the immediate postoperative setting during microdialysis.~OUTLINE: Patients are randomized to 1 of 3 arms.~ARM I: Patients undergo magnetic resonance imaging (MRI) and surgical resection at baseline. Patients receive eflornithine orally (PO) in combination with AMXT 1501 PO on days 1-5 post-surgery. Patients also undergo computed tomography (CT) after surgery and collection of blood on study.~ARM II: Patients undergo magnetic MRI and surgical resection at baseline. Patients receive placebo PO on days 1 and 2 post-surgery, and then receive eflornithine PO and AMXT 1501 PO on days 3-5 post-surgery. Patients also undergo CT after surgery and collection of blood on study.~ARM III: Patients undergo magnetic MRI and surgical resection at baseline. Patients receive eflornithine PO alone on days 1 and 2 post-surgery, then receive eflornithine PO in combination with AMXT 1501 PO on days 3-5 post-surgery. Patients also undergo CT after surgery and collection of blood on study.
This early phase I trial studies brain tumor (glioma) metabolism in response to difluoromethylornithine (DFMO) and polyamine transport inhibitor AMXT-1501 dicaprate (AMXT 1501) in patients with diffused or high grade glioma. Brain tumors use and produce certain molecules to survive and grow. DFMO is an irreversible inhibitor of ornithine decarboxylase, the enzyme catalyzing polyamine synthesis. AMXT 1501 is a polyamine transport inhibitor which prevents uptake of polyamines from the extracellular environment. This trial is being done to analyze how DFMO and AMXT 1501 affect brain tumor metabolism based on the molecules in the tumor's fluid.