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Polyamine Transport Inhibitor
DFMO + AMXT 1501 for Brain Tumor
Phase < 1
Recruiting
Led By Terence C. Burns, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months
Summary
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.
Who is the study for?
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.
What is being tested?
The study investigates how DFMO (a drug that blocks tumor growth molecules) and AMXT 1501 (which stops tumors from getting these molecules from outside) affect brain tumor metabolism. Participants will undergo surgery, imaging tests like CT/MRI scans, biospecimen collection, and microdialysis.
What are the potential side effects?
Potential side effects may include digestive issues due to oral medication intake; however specific side effects of DFMO and AMXT 1501 are not detailed here but could involve reactions similar to other chemotherapy agents such as fatigue or nausea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the tumor/brain extracellular guanidinoacetate ratio
Secondary study objectives
AMXT 1501 brain/plasma ratio over time
Central nervous system free drug levels from microdialysate - AMXT 1501
Central nervous system free drug levels from microdialysate - DFMO
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Arm I (MRI, resection, DFMO, AMXT 1501)Experimental Treatment8 Interventions
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.
Group II: Arm III (MRI, resection, DMFO, AMXT 1501)Active Control8 Interventions
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.
Group III: Arm II (MRI, resection, placebo, DMFO, AMXT 1501)Placebo Group8 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Computed Tomography
2017
Completed Phase 2
~2790
Eflornithine
1998
Completed Phase 3
~920
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Resection
2020
Completed Phase 2
~1440
Microdialysis
2013
Completed Early Phase 1
~350
Placement
2009
Completed Phase 2
~30
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Eflornithine (DFMO) and AMXT-1501 dicaprate target polyamine metabolism, which is essential for tumor growth. DFMO inhibits ornithine decarboxylase, reducing polyamine synthesis within tumor cells, while AMXT-1501 dicaprate blocks polyamine uptake from the extracellular environment.
This dual inhibition aims to starve tumor cells of necessary growth molecules, potentially slowing or stopping tumor progression. This targeted approach is significant for brain tumor patients as it may offer more effective and less toxic treatment options compared to conventional therapies.
Coagulation proteases and neurotransmitters in pathogenicity of glioblastoma multiforme.Inhibition of NF-κB signaling ablates the invasive phenotype of glioblastoma.Inhibition of thromboxane synthase activity improves glioblastoma response to alkylation chemotherapy.
Coagulation proteases and neurotransmitters in pathogenicity of glioblastoma multiforme.Inhibition of NF-κB signaling ablates the invasive phenotype of glioblastoma.Inhibition of thromboxane synthase activity improves glioblastoma response to alkylation chemotherapy.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,061,004 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,053 Total Patients Enrolled
Terence C. Burns, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
3 Previous Clinical Trials
330 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine levels, is within the required range.I have or am suspected to have a high-grade brain tumor.My hemoglobin level is at least 9 g/dL without recent blood transfusions.My platelet count is healthy without recent transfusions.I am 18 years old or older.My thyroid function is normal.My surgeon has planned a partial tumor removal due to its size or location.I cannot swallow pills or have issues absorbing medication.My white blood cell count is healthy without recent transfusions.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (MRI, resection, DFMO, AMXT 1501)
- Group 2: Arm II (MRI, resection, placebo, DMFO, AMXT 1501)
- Group 3: Arm III (MRI, resection, DMFO, AMXT 1501)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.