Clinical trial NCT05717153: Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Official title: Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501
Conditions: Diffuse Glioma
Malignant Glioma
Summary: 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.
Interventions:
description: Undergo collection of blood
name: Biospecimen Collection
other_name: Biological Sample Collection
Biospecimen Collected
Specimen Collection
type: Procedure
description: Undergo CT
name: Computed Tomography
other_name: CAT
CAT Scan
CT
CT Scan
Computed Axial Tomography
Computerized Axial Tomography
Computerized Tomography
tomography
type: Procedure
description: Given PO
name: Eflornithine
other_name: Alpha-Difluoromethylornithine
DFMO
Difluoromethylornithine
Difluromethylornithine
type: Drug
description: Undergo MRI
name: Magnetic Resonance Imaging
other_name: MR
MR Imaging
MRI
MRI Scan
Magnetic Resonance
Magnetic Resonance Imaging Scan
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
NMR Imaging
NMRI
Nuclear Magnetic Resonance Imaging
type: Procedure
description: Given PO
name: Polyamine Transport Inhibitor AMXT-1501 Dicaprate
other_name: AMX 513 Dicaprate
AMX513 Dicaprate
AMXT 1501 Dicaprate
AMXT-1501 Dicaprate
type: Drug
description: Undergo surgical resection
name: Resection
other_name: Surgical Resection
type: Procedure
description: Undergo Microdialysis
name: Microdialysis
type: Device
description: Undergo placement of catheters
name: Placement
other_name: Place
type: Procedure
Study arms:
design_group_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.
design_group_title: Arm I (MRI, resection, DFMO, AMXT 1501)
design_group_type: Experimental
design_group_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.
design_group_title: Arm II (MRI, resection, placebo, DMFO, AMXT 1501)
design_group_type: Placebo Comparator
design_group_description: 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.
design_group_title: Arm III (MRI, resection, DMFO, AMXT 1501)
design_group_type: Active Comparator
Sponsor: Mayo Clinic
Collaborators: National Cancer Institute
Drug name mappings:
name: Dicaprate
lang: EN
name: 依氟鸟氨酸
lang: CN
name: Eflornithine Hydrochloride
lang: EN