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Early Phase Study of DFMO and AMXT 1501 for Diffuse or High-Grade Glioma

This early-phase study is looking at how two drugs, eflornithine (DFMO) and AMXT 1501 dicaprate (AMXT 1501), affect brain tumors (gliomas). Brain tumors use certain molecules to grow, and these drugs aim to disrupt that process. DFMO stops the tumor from making these molecules, and AMXT 1501 prevents the tumor from taking them in. Researchers will analyze the fluid around the tumor to see how these drugs change its metabolism. You may be able to join if you are at least 18 years old and have a diffuse or high-grade glioma that requires surgery. The main goal is to see how these drugs change a specific ratio in the tumor's fluid. The study status is unclear and plans to enroll 18 participants.

Study design
This is an interventional study with 18 planned participants. Patients will be assigned to one of three groups (arms).
What's involved
You would undergo surgical resection, MRI, CT scans, blood collection, and have catheters placed for microdialysis. You would also take DFMO and AMXT 1501 by mouth for several days post-surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured up to 2 months after baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05717153

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalBasic science
Mayo Clinic
~18 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyEflornithineMagnetic Resonance ImagingPolyamine Transport Inhibitor AMXT-1501 DicaprateResection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the tumor/brain extracellular guanidinoacetate ratio
Measured over Baseline up to 2 months

Conditions

Diffuse Glioma
Malignant Glioma

Explore related trials

Diffuse GliomaMalignant Glioma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

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

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \>= 18 years
Clinical and radiographic evidence suggesting a diagnosis of a diffuse high grade glioma (HGG), or a prior diagnosis of a diffuse glioma
Planned subtotal resection or biopsy due to tumor location, size, or other clinical indication deemed appropriate by the surgeon
Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of cerebrospinal fluid (CSF) and blood samples collected on this protocol. Willing to remain in the hospital at Mayo Clinic (Rochester, MN) for three days added to their standard post-operative stay to undergo longitudinal microdialysis
Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L without transfusion within 7 days preceding the lab assessment (obtained =\< 14 days prior to registration)
Platelet \>= 100 x 10\^9/L, without transfusion within 7 days preceding the lab assessment (obtained =\< 14 days prior to registration)
Hemoglobin \>= 9 g/dL, without transfusion support within 7 days preceding the lab assessment (obtained =\< 14 days prior to registration)
Activated partial thromboplastin time or partial thromboplastin time (aPTT or PTT) =\< 1.5 x upper limit of normal (ULN) (obtained =\< 14 days prior to registration)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN (obtained =\< 14 days prior to registration)
Total serum bilirubin =\< 1.5 x ULN (obtained =\< 14 days prior to registration)
The patient is clinically euthyroid \[Thyroid Stimulating Hormone (TSH)\]
Serum creatinine =\< 1.5 x ULN or creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with serum creatinine levels above 1.5 x ULN (obtained =\< 14 days prior to registration)
Negative serum or urine pregnancy test is required for female subjects of childbearing age \< 14 days prior to registration

Exclusion

Inappropriate surgical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings
Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped
Unable to swallow tablets or who are at risk for impaired absorption of oral medication. NOTE: This includes but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection
Known hypersensitivity or allergy to DFMO or AMXT 1501
Contraindication to MRI or administration of gadolinium

What this trial measures

  • Change in the tumor/brain extracellular guanidinoacetate ratioBaseline up to 2 months

    Targeted metabolomics will be performed using the microdialysate aliquot collected at each time point to quantify guanidinoacetate content. Fold change values will be calculated between each time point within a patient. Fold changes values between time points will be compared across the three arms for statistically significant differences using a Wilcoxon signed rank test; p \< 0.05 will be considered statistically significant.