← Back to Search

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
Clinical and radiographic evidence suggesting a diagnosis of a diffuse high grade glioma (HGG), or a prior diagnosis of a diffuse glioma
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months
Awards & highlights

Study Summary

This trial studies how two drugs affect brain tumor metabolism to help fight gliomas.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have or am suspected to have a high-grade brain tumor.
Select...
My kidney function, measured by creatinine levels, is within the required range.
Select...
I am 18 years old or older.
Select...
My thyroid function is normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the tumor/brain extracellular guanidinoacetate ratio
Secondary outcome measures
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 more

Trial 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
Eflornithine
1998
Completed Phase 3
~830
Microdialysis
2013
Completed Early Phase 1
~350
Placement
2009
Completed Phase 2
~30
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Resection
2021
Completed Phase 2
~410

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,496 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,380 Total Patients Enrolled
Terence C. Burns, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
324 Total Patients Enrolled

Media Library

AMXT-1501 Dicaprate (Polyamine Transport Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05717153 — Phase < 1
Brain Tumor Research Study Groups: Arm III (MRI, resection, DMFO, AMXT 1501), Arm I (MRI, resection, DFMO, AMXT 1501), Arm II (MRI, resection, placebo, DMFO, AMXT 1501)
Brain Tumor Clinical Trial 2023: AMXT-1501 Dicaprate Highlights & Side Effects. Trial Name: NCT05717153 — Phase < 1
AMXT-1501 Dicaprate (Polyamine Transport Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05717153 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently accepting new participants?

"The clinicaltrials.gov website states that this trial is not currently recruiting; it was first posted on February 15th, 2023 and last updated on the 6th of February. However, there are still 347 other trials seeking to enrol participants at present."

Answered by AI
~10 spots leftby Jan 2027