Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT05717153

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

Led by Mayo Clinic · Updated on 2025-11-04

18

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical and radiographic evidence suggesting diffuse high grade glioma or prior diagnosis of diffuse glioma
  • Planned subtotal resection or biopsy as deemed appropriate by the surgeon
  • Provide written informed consent for this study and biorepository participation
  • Willingness to remain hospitalized for three days post-operatively for longitudinal microdialysis
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without recent transfusion
  • Platelet count ≥ 100 x 10^9/L without recent transfusion
  • Hemoglobin ≥ 9 g/dL without recent transfusion
  • Activated partial thromboplastin time (aPTT or PTT) ≤ 1.5 times upper limit of normal
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
  • Total serum bilirubin ≤ 1.5 times upper limit of normal
  • Clinically euthyroid (normal thyroid function)
  • Serum creatinine ≤ 1.5 times upper limit of normal or creatinine clearance ≥ 60 mL/min/1.73 m²
  • Negative pregnancy test for females of childbearing potential within 14 days prior to registration
Not Eligible

You will not qualify if you...

  • Not suitable for surgery due to medical history or uncontrolled illness limiting safety or compliance
  • Pregnant or nursing women, prisoners, or mentally handicapped individuals
  • Unable to swallow tablets or at risk for impaired absorption of oral medications (e.g., refractory vomiting, gastric or intestinal surgery)
  • Known allergy or hypersensitivity to DFMO or AMXT 1501
  • Contraindications to MRI or gadolinium administration

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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