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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05717153
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Diffuse Glioma
  • Malignant Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Eflornithine — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Polyamine Transport Inhibitor AMXT-1501 Dicaprate — DRUG
    Given PO
  • Resection — PROCEDURE
    Undergo surgical resection
  • Microdialysis — DEVICE
    Undergo Microdialysis
  • Placement — PROCEDURE
    Undergo placement of catheters

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Oct 2025
Primary completion
Jan 15, 2027
Completion
Sep 15, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm I (MRI, resection, DFMO, AMXT 1501)
    Patients undergo magnetic resonance imaging (MRI) and surgical resection at baseline. Patients receive eflornithine PO in combination with AMXT 1501 PO on days 1-5 post-surgery. Patients also undergo CT after surgery and collection of blood on study.
  • Placebo Comparator: Arm II (MRI, resection, placebo, DMFO, AMXT 1501)
    Patients undergo magnetic MRI and surgical resection at baseline. Patients receive placebo PO on days 1 and 2 post-surgery, and then receive eflornithine PO and AMXT 1501 PO on days 3-5 post-surgery. Patients also undergo CT after surgery and collection of blood on study.
  • Active Comparator: Arm III (MRI, resection, DMFO, AMXT 1501)
    Patients undergo magnetic MRI and surgical resection at baseline. Patients receive eflornithine PO alone on days 1 and 2 post-surgery, then receive eflornithine PO in combination with AMXT 1501 PO on days 3-5 post-surgery. Patients also undergo CT after surgery and collection of blood on study.

Primary Outcome Measure

Change in the tumor/brain extracellular guanidinoacetate ratio [ Time Frame: Baseline up to 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Terry Burns, MD, PhD (PRINCIPAL_INVESTIGATOR)

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