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RECRUITING
NCT05717153
EARLY_PHASE1

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2023-10-01

Completion Date

2027-09-15

Last Updated

2025-11-04

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Eflornithine

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Polyamine Transport Inhibitor AMXT-1501 Dicaprate

Given PO

PROCEDURE

Resection

Undergo surgical resection

DEVICE

Microdialysis

Undergo Microdialysis

PROCEDURE

Placement

Undergo placement of catheters

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States