Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
NCT ID: NCT05717153
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
18 participants
INTERVENTIONAL
2023-10-01
2027-09-15
Brief Summary
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Detailed Description
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I. Determine how polyamine depletion impacts extracellular guanidinoacetate abundance.
SECONDARY OBJECTIVES:
I. Determine the impact of polyamine depletion on polyamine abundance and the global extracellular metabolome within live human gliomas, in situ.
II. Assess the feasibility of longitudinal microdialysis to evaluate pharmacodynamic responses of in situ gliomas to therapeutic intervention in a post-operative setting.
III. Assess the central nervous system (CNS) pharmacokinetics of DFMO and AMXT 1501.
IV. Adverse effects of study drugs in the immediate postoperative setting during microdialysis.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo surgical resection with magnetic resonance imaging (MRI) and placement of catheters for microdialysis at baseline. Patients receive DFMO orally (PO) in combination with AMXT 1501 PO on days 1-5 post-surgery in the absence of disease progression or unacceptable toxicity. Patients also continue microdialysate collection as well as undergo computed tomography (CT) and collection of blood on study.
ARM II: Patients undergo surgical resection with MRI and placement of catheters for microdialysis at baseline. Patients receive DFMO PO and AMXT 1501 PO on days 3-5 post-surgery in the absence of disease progression or unacceptable toxicity. Patients also continue microdialysate collection, as well as undergo CT and collection of blood on study.
ARM III: Patients undergo surgical resection with MRI and placement of catheters for microdialysis at baseline. Patients receive DFMO 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 in the absence of disease progression or unacceptable toxicity. Patients also continue microdialysate collection, as well as undergo CT and collection of blood on study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
Biospecimen Collection
Undergo collection of blood
Computed Tomography
Undergo CT
Eflornithine
Given PO
Magnetic Resonance Imaging
Undergo MRI
Polyamine Transport Inhibitor AMXT-1501 Dicaprate
Given PO
Resection
Undergo surgical resection
Microdialysis
Undergo Microdialysis
Placement
Undergo placement of catheters
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.
Biospecimen Collection
Undergo collection of blood
Computed Tomography
Undergo CT
Eflornithine
Given PO
Magnetic Resonance Imaging
Undergo MRI
Polyamine Transport Inhibitor AMXT-1501 Dicaprate
Given PO
Resection
Undergo surgical resection
Microdialysis
Undergo Microdialysis
Placement
Undergo placement of catheters
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.
Biospecimen Collection
Undergo collection of blood
Computed Tomography
Undergo CT
Eflornithine
Given PO
Magnetic Resonance Imaging
Undergo MRI
Polyamine Transport Inhibitor AMXT-1501 Dicaprate
Given PO
Resection
Undergo surgical resection
Microdialysis
Undergo Microdialysis
Placement
Undergo placement of catheters
Interventions
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Biospecimen Collection
Undergo collection of blood
Computed Tomography
Undergo CT
Eflornithine
Given PO
Magnetic Resonance Imaging
Undergo MRI
Polyamine Transport Inhibitor AMXT-1501 Dicaprate
Given PO
Resection
Undergo surgical resection
Microdialysis
Undergo Microdialysis
Placement
Undergo placement of catheters
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Terence C. Burns, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2022-10375
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-005690
Identifier Type: -
Identifier Source: org_study_id
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