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

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.

Conditions

• Diffuse Glioma
• Malignant Glioma

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Terence C. Burns, MD, PhD · Mayo Clinic in Rochester

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2027-01-15

Completion

2027-09-15

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations