At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Clinical and radiographic evidence of diffuse high-grade glioma or prior diffuse glioma diagnosis
- ✓Planned subtotal resection or biopsy
- ✓Willing to remain hospitalized for three additional days for longitudinal microdialysis
- ✕Inappropriate surgical candidate due to medical history or uncontrolled illness affecting safety or compliance
- ✕Vulnerable populations including pregnant/nursing women, prisoners, mentally handicapped
- ✕Unable to swallow tablets or at risk for impaired oral medication absorption
- ✕Known hypersensitivity or allergy to DFMO or AMXT 1501
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501
In Brief
A Early Phase 1 clinical trial evaluating Biospecimen Collection, Computed Tomography, and 6 other interventions for Diffuse Glioma and Malignant Glioma. Currently recruiting, targeting 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Undergo collection of blood
Undergo CT
Given PO
Undergo MRI
Given PO
Undergo surgical resection
Undergo Microdialysis
Undergo placement of catheters