Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

Launched by MAYO CLINIC · Feb 6, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how two medications, eflornithine (DFMO) and AMXT 1501, affect the metabolism of brain tumors known as diffuse or high-grade gliomas. These tumors rely on certain substances to grow, and the study aims to understand how these drugs might change the way tumors use and produce these substances. This trial is currently recruiting adult patients who are at least 18 years old and have been diagnosed with a diffuse high-grade glioma. Participants will need to have surgery planned for their tumor and be willing to stay in the hospital for three extra days after surgery for further testing.

To participate, individuals must meet several health criteria, including specific blood counts and liver function tests. Participants can expect to provide informed consent, allowing researchers to collect and analyze samples from their cerebrospinal fluid and blood. This study is being conducted at the Mayo Clinic in Rochester, MN, and is focused on better understanding brain tumor treatment options through metabolic changes. If you or a loved one are considering participation, it is important to discuss this trial with your healthcare team to see if it might be a good fit.

Gender

ALL

Eligibility criteria

• 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 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/ partial thromboplastin time (aPTT/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
• • 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
• Exclusion Criteria:
• • Patients who are not appropriate 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
• • Participants who are 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
• • Patients with known hypersensitivity or allergy to DFMO or AMXT 1501
• • Contraindication to MRI or administration of gadolinium