RecruitingEarly Phase 1NCT05717153

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

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501


Sponsor

Mayo Clinic

Enrollment

18 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether two investigational drugs (DFMO and AMXT 1501) that block a specific cell-growth pathway (polyamine synthesis) can alter the metabolism inside brain tumors. Patients receiving these drugs before brain tumor surgery allow researchers to measure changes inside the tumor using a special monitoring technique during recovery. **You may be eligible if...** - You are 18 or older with a suspected or confirmed high-grade brain tumor (diffuse glioma), based on clinical and imaging findings - You are scheduled for a biopsy or partial removal of the tumor at Mayo Clinic (Rochester, MN) - You are willing to stay in the hospital for up to 3 extra days after surgery for monitoring - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You are not a suitable candidate for surgery due to medical history or current illnesses - You are pregnant or breastfeeding - You have another serious medical condition that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

PROCEDUREPlacement

Undergo placement of catheters


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT05717153


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