DFMO + AMXT 1501 for Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies how two drugs, DFMO and AMXT 1501, affect brain tumors in patients with aggressive brain tumors. DFMO stops the production of growth molecules, and AMXT 1501 blocks their intake. The goal is to see if these drugs can effectively starve the tumor.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the DFMO + AMXT 1501 treatment generally safe for humans?
DFMO (also known as eflornithine) has been studied for safety in humans, showing mainly mild side effects like nausea and vomiting, with some cases of hearing issues (ototoxicity) leading to discontinuation in a small number of patients. Serious blood-related side effects (thrombocytopenia) were not common in short-term treatments.12345
What makes the drug DFMO + AMXT 1501 unique for treating brain tumors?
What data supports the effectiveness of the drug DFMO + AMXT 1501 for brain tumors?
Research shows that DFMO can effectively reach brain tumors in rats, suggesting it may be useful in treating brain tumors. Additionally, intranasal administration of deferoxamine, a component of the treatment, has been shown to increase brain exposure and provide protection in rat models of stroke, indicating potential benefits for brain conditions.67111213
Who Is on the Research Team?
Terence C. Burns, MD, PhD
Principal Investigator
Mayo Clinic in Rochester
Are You a Good Fit for This Trial?
This trial is for adults with diffuse or high-grade glioma who can swallow tablets, are not pregnant, and have no allergies to the drugs being tested. They must have proper kidney function, normal blood counts, stable thyroid function, and be able to stay in the hospital for additional days post-surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Resection and Baseline Assessment
Patients undergo surgical resection with MRI and placement of catheters for microdialysis at baseline
Treatment
Patients receive DFMO and AMXT 1501 orally post-surgery, with microdialysate collection and CT scans
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AMXT-1501 Dicaprate
- DFMO
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Cancer Institute (NCI)
Collaborator