Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501
Mayo Clinic
Summary
This early phase I trial studies brain tumor (glioma) metabolism in response to eflornithine (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.
Description
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 DFMO and AMXT 1501. IV. Adverse effects of study drugs in the immediate postoperativ…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>= 18 years * Clinical and radiographic evidence suggesting a diagnosis of a diffuse high grade glioma (HGG), or a prior diagnosis of a diffuse glioma * Planned subtotal resection or biopsy due to tumor location, size, or other clinical indication deemed appropriate by the surgeon * Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of cerebrospinal fluid (CSF) and blood samples collected on this protocol. Willing to remain in the hospital at Mayo Clinic (Rochester, MN) for three days added to their standard pos…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood
- ProcedureComputed Tomography
Undergo CT
- DrugEflornithine
Given PO
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- DrugPolyamine Transport Inhibitor AMXT-1501 Dicaprate
Given PO
- ProcedureResection
Undergo surgical resection
- DeviceMicrodialysis
Undergo Microdialysis
Location
- Mayo Clinic in RochesterRochester, Minnesota