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Polyamine Transport Inhibitor

DFMO + AMXT 1501 for Brain Tumor

Q: Is this research endeavor currently accepting new participants?

<p>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.</p>

Phase < 1

Recruiting

Led By Terence C Burns

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

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 months

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

Placement

2009

Completed Phase 2

~30

Biospecimen Collection

2004

Completed Phase 2

~1720

Eflornithine

1998

Completed Phase 3

~830

Resection

2023

Completed Phase 2

~420

Microdialysis

2013

Completed Early Phase 1

~350

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,233 Previous Clinical Trials

3,771,811 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,703 Previous Clinical Trials

40,931,735 Total Patients Enrolled

Terence C BurnsPrincipal InvestigatorMayo Clinic in Rochester

4 Previous Clinical Trials

416 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 I (MRI, resection, DFMO, AMXT 1501), Arm II (MRI, resection, placebo, DMFO, AMXT 1501), Arm III (MRI, resection, 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

Recent research and studies

clinicaltrials.govStudy

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

Terry Burns 2023. "Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05717153.