Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Glioma | Diffuse Glioma | ONTOLOGY_EXACT | 0.98 |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Eflornithine | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Microdialysis | Device | — | UNRESOLVED |
| Placement | Procedure | — | UNRESOLVED |
| Polyamine Transport Inhibitor AMXT-1501 Dicaprate | Drug | — | UNRESOLVED |
| Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (MRI, resection, DFMO, AMXT 1501)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Drug: Eflornithine
- Procedure: Magnetic Resonance Imaging
- Drug: Polyamine Transport Inhibitor AMXT-1501 Dicaprate
- Procedure: Resection
- Device: Microdialysis
- Procedure: Placement
- type
- PLACEBO_COMPARATOR
- label
- Arm II (MRI, resection, placebo, DMFO, AMXT 1501)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available