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Diffuse GliomaCancerProcedureDrugDeviceEarly Phase 1

What this study is

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.

What's being tested

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo collection of blood

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT

  • Eflornithine

    Intervention · DRUG

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Polyamine Transport Inhibitor AMXT-1501 Dicaprate

    Intervention · DRUG

  • Resection

    Intervention · PROCEDURE

    Undergo surgical resection

  • Microdialysis

    Intervention · DEVICE

    Undergo Microdialysis

  • Placement

    Intervention · PROCEDURE

    Undergo placement of catheters

Both Eflornithine and Polyamine Transport Inhibitor AMXT-1501 Dicaprate

Given PO

Study details

Official title
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501
Sponsor
Mayo Clinic
Conditions
Diffuse Glioma · Malignant Glioma
Enrolling
18 people
Starts
2023-09-15
Est. completion
2028-02-29
Design
Double-blind, randomized, parallel groups, Early Phase 1
Record
View on ClinicalTrials.gov ↗