Clinical Trials Logo

Clinical 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. 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.


Clinical Trial Description

PRIMARY OBJECTIVE: I. Determine how polyamine depletion impacts extracellular guanidinoacetate abundance. SECONDARY OBJECTIVES: I. 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


Related Conditions & MeSH terms


NCT number NCT05717153
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Early Phase 1
Start date October 1, 2023
Completion date September 15, 2027

See also
  Status Clinical Trial Phase
Terminated NCT02764151 - First in Patient Study for PF-06840003 in Malignant Gliomas Phase 1
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Completed NCT00953121 - Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG) Phase 2
Completed NCT00766467 - A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Phase 2
Active, not recruiting NCT03233204 - Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT05045027 - Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma Early Phase 1
Completed NCT02507583 - Antisense102: Pilot Immunotherapy for Newly Diagnosed Malignant Glioma Phase 1
Completed NCT04109209 - Psychological Intervention For Brain Tumor Caregivers N/A
Recruiting NCT04937413 - The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation Early Phase 1
Completed NCT03615404 - Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma Phase 1
Active, not recruiting NCT04175301 - Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas. Phase 2
Terminated NCT02659800 - Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas Phase 1
Active, not recruiting NCT02323880 - Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas Phase 1
Completed NCT00782756 - Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma Phase 2
Terminated NCT02855086 - Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery Phase 1/Phase 2
Completed NCT02861222 - Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma Phase 1
Completed NCT00634231 - A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors Phase 1
Completed NCT01792505 - Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma Phase 1
Completed NCT00190723 - A Study of LY317615 in Patients With Brain Tumors Phase 2
Recruiting NCT04323046 - Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults Phase 1