[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494359":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":105,"centralContacts":110,"locations":116,"responsibleParty":134,"collaborators":136,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":98,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":98,"enrollmentInfo":149,"targetDuration":98,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":98,"overallStatus":118,"whyStopped":98,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14,15,16,17,18,19,20],"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",{"label":22,"type":23,"description":24,"interventionNames":25},"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.",[13,14,15,16,17,18,19,20],{"label":27,"type":28,"description":29,"interventionNames":30},"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.",[13,14,15,16,17,18,19,20],[32,41,54,64,79,87,93,99],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","Biospecimen Collection","Undergo collection of blood",[9,22,27],[38,39,40],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":33,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Computed Tomography","Undergo CT",[9,22,27],[46,47,48,49,50,51,52,53],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized Tomography","CT","CT Scan","tomography",{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"DRUG","Eflornithine","Given PO",[9,22,27],[60,61,62,63],"Alpha-Difluoromethylornithine","DFMO","Difluoromethylornithine","Difluromethylornithine",{"type":33,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"Magnetic Resonance Imaging","Undergo MRI",[9,22,27],[69,70,71,72,73,74,75,76,77,78],"Magnetic Resonance","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging",{"type":55,"name":80,"description":57,"armGroupLabels":81,"otherNames":82},"Polyamine Transport Inhibitor AMXT-1501 Dicaprate",[9,22,27],[83,84,85,86],"AMX 513 Dicaprate","AMX513 Dicaprate","AMXT 1501 Dicaprate","AMXT-1501 Dicaprate",{"type":33,"name":88,"description":89,"armGroupLabels":90,"otherNames":91},"Resection","Undergo surgical resection",[9,22,27],[92],"Surgical Resection",{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"DEVICE","Microdialysis","Undergo Microdialysis",[9,22,27],null,{"type":33,"name":100,"description":101,"armGroupLabels":102,"otherNames":103},"Placement","Undergo placement of catheters",[9,22,27],[104],"Place",[106],{"name":107,"affiliation":108,"role":109},"Terence C. Burns, MD, PhD","Mayo Clinic in Rochester","PRINCIPAL_INVESTIGATOR",[111],{"name":112,"role":113,"phone":114,"phoneExt":98,"email":115},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",[117],{"facility":108,"status":118,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":130},"RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":125,"coordinates":126},"Point",[127,128],-92.4699,44.02163,{"lat":128,"lon":127},[131,132],{"name":112,"role":113,"phone":114,"phoneExt":98,"email":115},{"name":133,"role":109,"phone":98,"phoneExt":98,"email":98},"Terry Burns, MD, PhD",{"type":135,"investigatorFullName":98,"investigatorTitle":98,"investigatorAffiliation":98,"oldNameTitle":98,"oldOrganization":98},"SPONSOR",[137],{"name":138,"class":139},"National Cancer Institute (NCI)","NIH","100494359","early-phase-1-intratumoral-extracellular-metabolic-impact-of-dfmo-and-amxt-1501-in-patients-with-diffuse-or-high-grade-glioma-100494359",false,"NCT05717153","Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma","Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Clinical and radiographic evidence suggesting a diagnosis of a diffuse high grade glioma (HGG), or a prior diagnosis of a diffuse glioma\n* Planned subtotal resection or biopsy due to tumor location, size, or other clinical indication deemed appropriate by the surgeon\n* 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\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL without transfusion within 7 days preceding the lab assessment (obtained =\\\u003C 14 days prior to registration)\n* Platelet \\>= 100 x 10\\^9\u002FL, without transfusion within 7 days preceding the lab assessment (obtained =\\\u003C 14 days prior to registration)\n* Hemoglobin \\>= 9 g\u002FdL, without transfusion support within 7 days preceding the lab assessment (obtained =\\\u003C 14 days prior to registration)\n* Activated partial thromboplastin time or partial thromboplastin time (aPTT or PTT) =\\\u003C 1.5 x upper limit of normal (ULN) (obtained =\\\u003C 14 days prior to registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (obtained =\\\u003C 14 days prior to registration)\n* Total serum bilirubin =\\\u003C 1.5 x ULN (obtained =\\\u003C 14 days prior to registration)\n* The patient is clinically euthyroid \\[Thyroid Stimulating Hormone (TSH)\\]\n* Serum creatinine =\\\u003C 1.5 x ULN or creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for patients with serum creatinine levels above 1.5 x ULN (obtained =\\\u003C 14 days prior to registration)\n* Negative serum or urine pregnancy test is required for female subjects of childbearing age \\\u003C 14 days prior to registration\n\nExclusion Criteria:\n\n* Inappropriate surgical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings\n* Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped\n* 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\u002Fbypass, and duodenal\u002Fjejunal resection\n* Known hypersensitivity or allergy to DFMO or AMXT 1501\n* Contraindication to MRI or administration of gadolinium","ALL","18 Years",{"count":150,"type":151},18,"ESTIMATED","INTERVENTIONAL",[154],"EARLY_PHASE1","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.",[157,158],"Diffuse Glioma","Malignant Glioma","2025-10-31",{"date":161,"type":162},"2025-11-04","ACTUAL",{"date":164,"type":162},"2023-10-01",{"date":166,"type":151},"2027-09-15",{"name":5,"class":6},1]