Diffuse GliomaEarly Phase 1NCT05717153
Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
A Early Phase 1 study testing Biospecimen Collection, Computed Tomography and Eflornithine in people with Diffuse Glioma and Malignant Glioma, run by Mayo Clinic at 1 site in United States.
Trial summary
This early phase I trial studies brain tumor (glioma) metabolism in response to eflornithine (DFMO) and polyamine transport inhibitor AMXT-1501 dicaprate (AMXT 1501) in patients with diffused or high grade glioma. Brain tumors use and produce certain molecules to survive and grow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Glioma, Malignant Glioma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Eflornithine
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 29 Feb 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 or biopsy 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)
Show all 13Show fewer
- Hemoglobin >= 9 g/dL, without transfusion support within 7 days preceding the lab assessment (obtained =< 14 days prior to registration)
- Activated partial thromboplastin time or partial thromboplastin time (aPTT or 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 [Thyroid Stimulating Hormone (TSH)]
- 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 < 14 days prior to registration
Who cannot join
- Inappropriate 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
- 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
- Known hypersensitivity or allergy to DFMO or AMXT 1501
- Contraindication to MRI or administration of gadolinium
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Neurosurgery Study Team contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Neurosurgery Study Team, 507-422-5673
About this study
Official title: Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501
This early phase I trial studies brain tumor (glioma) metabolism in response to eflornithine (DFMO) and polyamine transport inhibitor AMXT-1501 dicaprate (AMXT 1501) in patients with diffused or high grade glioma. Brain tumors use and produce certain molecules to survive and grow. DFMO is an irreversible inhibitor of ornithine decarboxylase, the enzyme catalyzing polyamine synthesis. AMXT 1501 is a polyamine transport inhibitor which prevents uptake of polyamines from the extracellular environment. This trial is being done to analyze how DFMO and AMXT 1501 affect brain tumor metabolism based on the molecules in the tumor's fluid.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine how polyamine depletion impacts extracellular guanidinoacetate abundance.
SECONDARY OBJECTIVES:
- Determine the impact of polyamine depletion on polyamine abundance and the global extracellular metabolome within live human gliomas, in situ.
II. Assess the feasibility of longitudinal microdialysis to evaluate pharmacodynamic responses of in situ gliomas to therapeutic intervention in a post-operative setting.
III. Assess the central nervous system (CNS) pharmacokinetics of DFMO and AMXT 1501.
IV. Adverse effects of study drugs in the immediate postoperative setting during microdialysis.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo surgical resection with magnetic resonance imaging (MRI) and placement of catheters for microdialysis at baseline. Patients receive DFMO orally (PO) in combination with AMXT 1501 PO on days 1-5 post-surgery in the absence of disease progression or unacceptable toxicity. Patients also continue microdialysate collection as well as undergo computed tomography (CT) and collection of blood on study.
ARM II: Patients undergo surgical resection with MRI and placement of catheters for microdialysis at baseline. Patients receive DFMO PO and AMXT 1501 PO on days 3-5 post-surgery in the absence of disease progression or unacceptable toxicity. Patients also continue microdialysate collection, as well as undergo CT and collection of blood on study.
ARM III: Patients undergo surgical resection with MRI and placement of catheters for microdialysis at baseline. Patients receive DFMO 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 in the absence of disease progression or unacceptable toxicity. Patients also continue microdialysate collection, as well as undergo CT and collection of blood on study.
- Conditions
- Diffuse Glioma, Malignant Glioma
- Being tested
- Biospecimen Collection, Computed Tomography, Eflornithine, Magnetic Resonance Imaging, Polyamine Transport Inhibitor AMXT-1501 Dicaprate
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
EflornithineDrug
Also called Alpha-Difluoromethylornithine, DFMO, Difluoromethylornithine, Difluromethylornithine
Given PO
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR
Undergo MRI
Polyamine Transport Inhibitor AMXT-1501 DicaprateDrug
Also called AMX 513 Dicaprate, AMX513 Dicaprate, AMXT 1501 Dicaprate, AMXT-1501 Dicaprate
Given PO
ResectionProcedure or surgery
Also called Surgical Resection
Undergo surgical resection
MicrodialysisDevice
Undergo Microdialysis
PlacementProcedure or surgery
Also called Place
Undergo placement of catheters
| Study group | Role | What they receive |
|---|---|---|
| Arm I (MRI, resection, DFMO, AMXT 1501) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Eflornithine; Procedure: Magnetic Resonance Imaging; Drug: Polyamine Transport Inhibitor AMXT-1501 Dicaprate; Procedure: Resection; Device: Microdialysis; Procedure: Placement |
| Arm II (MRI, resection, placebo, DMFO, AMXT 1501) | Placebo comparator | 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Eflornithine; Procedure: Magnetic Resonance Imaging; Drug: Polyamine Transport Inhibitor AMXT-1501 Dicaprate; Procedure: Resection; Device: Microdialysis; Procedure: Placement |
| Arm III (MRI, resection, DMFO, AMXT 1501) | Active comparator | 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Eflornithine; Procedure: Magnetic Resonance Imaging; Drug: Polyamine Transport Inhibitor AMXT-1501 Dicaprate; Procedure: Resection; Device: Microdialysis; Procedure: Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the tumor/brain extracellular guanidinoacetate ratio
Targeted metabolomics will be performed using the microdialysate aliquot collected at each time point to quantify guanidinoacetate content. Fold change values will be calculated between each time point within a patient. Fold changes values between time points will be compared across the three arms for statistically significant differences using a Wilcoxon signed rank test; p < 0.05 will be considered statistically significant.
Measured: Baseline up to 2 months
Secondary outcomes (6)
Measured extracellular levels of glutamate in tumor and brain microdialysates
Targeted metabolomics will be performed for each time point's microdialysate, assaying for polyamines (putrescine, spermine, and spermidine), in addition to ornithine and glutamate. Fold change values will be calculated between each time point within a patient. Fold changes values between time points will be compared across the three arms for statistically significant differences using a Wilcoxon signed rank test; p < 0.05 will be considered statistically significant.
Measured: Up to 2 months
Proportion of longitudinal microdialysis aliquots containing > 30 uL of microdialysate
Targeted metabolomics will be performed for each time point's microdialysate, assaying for polyamines (putrescine, spermine, and spermidine), in addition to ornithine and glutamate. Fold change values will be calculated between each time point within a patient. Fold changes values between time points will be compared across the three arms for statistically significant differences using a Wilcoxon signed rank test; p < 0.05 will be considered statistically significant.
Measured: Up to post-operative day 5
Central nervous system free drug levels from microdialysate - DFMO
Drug levels of difluoromethylornithine (eflornithine [DFMO]) at each time point will be calculated for pharmacokinetic analyses by Aminex Therapeutics to determine time of peak concentration (hr), maximum drug concentration (ng/mL), and area under the curve 0-t (hr*ng/mL).
Measured: Up to 2 months
Central nervous system free drug levels from microdialysate - AMXT 1501
Polyamine transport inhibitor AMXT-1501 dicaprate (AMXT 1501) at each time point will be calculated for pharmacokinetic analyses by Aminex Therapeutics to determine time of peak concentration (hr), maximum drug concentration (ng/mL), and area under the curve 0-t (hr*ng/mL).
Measured: Up to 2 months
AMXT 1501 brain/plasma ratio over time
Will be assessed via longitudinal microdialysis to understand how AMXT 1501 is distributed in Central Nervous System (CNS) tissue with and without tumor as compared to plasma levels over time.
Measured: Up to 2 months
Incidence of adverse events
Although no significant additional risks are anticipated in the proposed context, safety data will be assessed to evaluate for any unanticipated adverse events.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Sep 2023
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse GliomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Terence C. Burns, MD, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717153
- Sponsor's protocol ID
- 22-005690
- Other IDs
- R37CA276851, NCI-2022-10375, CR250702-DFMO-AMXT
- Status last verified
- Nov 2026
- First submitted
- 23 Jan 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501
- ClinicalTrials.gov ID
- NCT05717153
- Acronym / sponsor ID
- 22-005690
- Conditions
- Diffuse Glioma, Malignant Glioma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This early phase I trial studies brain tumor (glioma) metabolism in response to eflornithine (DFMO) and polyamine transport inhibitor AMXT-1501 dicaprate (AMXT 1501) in patients with diffused or high grade glioma. Brain tumors use and produce certain molecules to survive and grow. DFMO is an irreversible inhibitor of ornithine decarboxylase, the enzyme catalyzing polyamine synthesis. AMXT 1501 is a polyamine transport inhibitor which prevents uptake of polyamines from the extracellular environment. This trial is being done to analyze how DFMO and AMXT 1501 affect brain tumor metabolism based on the molecules in the tumor's fluid.
Detailed description
PRIMARY OBJECTIVE:
- Determine how polyamine depletion impacts extracellular guanidinoacetate abundance.
SECONDARY OBJECTIVES:
- Determine the impact of polyamine depletion on polyamine abundance and the global extracellular metabolome within live human gliomas, in situ.
II. Assess the feasibility of longitudinal microdialysis to evaluate pharmacodynamic responses of in situ gliomas to therapeutic intervention in a post-operative setting.
III. Assess the central nervous system (CNS) pharmacokinetics of DFMO and AMXT 1501.
IV. Adverse effects of study drugs in the immediate postoperative setting during microdialysis.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo surgical resection with magnetic resonance imaging (MRI) and placement of catheters for microdialysis at baseline. Patients receive DFMO orally (PO) in combination with AMXT 1501 PO on days 1-5 post-surgery in the absence of disease progression or unacceptable toxicity. Patients also continue microdialysate collection as well as undergo computed tomography (CT) and collection of blood on study.
ARM II: Patients undergo surgical resection with MRI and placement of catheters for microdialysis at baseline. Patients receive DFMO PO and AMXT 1501 PO on days 3-5 post-surgery in the absence of disease progression or unacceptable toxicity. Patients also continue microdialysate collection, as well as undergo CT and collection of blood on study.
ARM III: Patients undergo surgical resection with MRI and placement of catheters for microdialysis at baseline. Patients receive DFMO 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 in the absence of disease progression or unacceptable toxicity. Patients also continue microdialysate collection, as well as undergo CT and collection of blood on study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (MRI, resection, DFMO, AMXT 1501) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Eflornithine, Procedure: Magnetic Resonance Imaging, Drug: Polyamine Transport Inhibitor AMXT-1501 Dicaprate, Procedure: Resection, Device: Microdialysis, Procedure: PlacementPatients 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. |
| Arm II (MRI, resection, placebo, DMFO, AMXT 1501) | Placebo comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Eflornithine, Procedure: Magnetic Resonance Imaging, Drug: Polyamine Transport Inhibitor AMXT-1501 Dicaprate, Procedure: Resection, Device: Microdialysis, Procedure: PlacementPatients 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. |
| Arm III (MRI, resection, DMFO, AMXT 1501) | Active comparator | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Eflornithine, Procedure: Magnetic Resonance Imaging, Drug: Polyamine Transport Inhibitor AMXT-1501 Dicaprate, Procedure: Resection, Device: Microdialysis, Procedure: PlacementPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 or biopsy 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)
Key exclusion criteria (5 listed)
- Inappropriate 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
- 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
- Known hypersensitivity or allergy to DFMO or AMXT 1501
- Contraindication to MRI or administration of gadolinium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood | Procedure or surgery | Arm I (MRI, resection, DFMO, AMXT 1501), Arm II (MRI, resection, placebo, DMFO, AMXT 1501), Arm III (MRI, resection, DMFO, AMXT 1501) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Arm I (MRI, resection, DFMO, AMXT 1501), Arm II (MRI, resection, placebo, DMFO, AMXT 1501), Arm III (MRI, resection, DMFO, AMXT 1501) |
| EflornithineAlso: Alpha-Difluoromethylornithine, DFMO, Difluoromethylornithine, DifluromethylornithineGiven PO | Drug | Arm I (MRI, resection, DFMO, AMXT 1501), Arm II (MRI, resection, placebo, DMFO, AMXT 1501), Arm III (MRI, resection, DMFO, AMXT 1501) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRUndergo MRI | Procedure or surgery | Arm I (MRI, resection, DFMO, AMXT 1501), Arm II (MRI, resection, placebo, DMFO, AMXT 1501), Arm III (MRI, resection, DMFO, AMXT 1501) |
| Polyamine Transport Inhibitor AMXT-1501 DicaprateAlso: AMX 513 Dicaprate, AMX513 Dicaprate, AMXT 1501 Dicaprate, AMXT-1501 DicaprateGiven PO | Drug | Arm I (MRI, resection, DFMO, AMXT 1501), Arm II (MRI, resection, placebo, DMFO, AMXT 1501), Arm III (MRI, resection, DMFO, AMXT 1501) |
| ResectionAlso: Surgical ResectionUndergo surgical resection | Procedure or surgery | Arm I (MRI, resection, DFMO, AMXT 1501), Arm II (MRI, resection, placebo, DMFO, AMXT 1501), Arm III (MRI, resection, DMFO, AMXT 1501) |
| MicrodialysisUndergo Microdialysis | Device | Arm I (MRI, resection, DFMO, AMXT 1501), Arm II (MRI, resection, placebo, DMFO, AMXT 1501), Arm III (MRI, resection, DMFO, AMXT 1501) |
| PlacementAlso: PlaceUndergo placement of catheters | Procedure or surgery | Arm I (MRI, resection, DFMO, AMXT 1501), Arm II (MRI, resection, placebo, DMFO, AMXT 1501), Arm III (MRI, resection, DMFO, AMXT 1501) |
Primary outcome
Change in the tumor/brain extracellular guanidinoacetate ratio
Time frame: Baseline up to 2 months
Targeted metabolomics will be performed using the microdialysate aliquot collected at each time point to quantify guanidinoacetate content. Fold change values will be calculated between each time point within a patient. Fold changes values between time points will be compared across the three arms for statistically significant differences using a Wilcoxon signed rank test; p < 0.05 will be considered statistically significant.
6 secondary outcomes
Measured extracellular levels of glutamate in tumor and brain microdialysates
Time frame: Up to 2 months
Proportion of longitudinal microdialysis aliquots containing > 30 uL of microdialysate
Time frame: Up to post-operative day 5
Central nervous system free drug levels from microdialysate - DFMO
Time frame: Up to 2 months
Central nervous system free drug levels from microdialysate - AMXT 1501
Time frame: Up to 2 months
AMXT 1501 brain/plasma ratio over time
Time frame: Up to 2 months
Incidence of adverse events
Time frame: Up to 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neurosurgery Study Team contact
Terence C. Burns, MD, PhD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biospecimen Collection, Computed Tomography and Eflornithine in people with Diffuse Glioma and Malignant Glioma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the tumor/brain extracellular guanidinoacetate ratio (time frame: Baseline up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.