Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Computed Tomography
- Eflornithine
- Magnetic Resonance Imaging
- Polyamine Transport Inhibitor AMXT-1501 Dicaprate
- Resection
- Microdialysis
- Placement
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov