Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Device
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 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)

• Hemoglobin \>= 9 g/dL, without transfusion support within 7 days preceding the lab assessment (obtained =\< 14 days prior to registration)

• Activated partial thromboplastin time/ partial thromboplastin time (aPTT/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

• 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

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2027-09-15
Participants
Target number of participants: 15
Treatments
Experimental: Arm I (MRI, resection, DFMO, AMXT 1501)
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.
Placebo_comparator: Arm II (MRI, resection, placebo, DMFO, AMXT 1501)
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.
Active_comparator: Arm III (MRI, resection, DMFO, AMXT 1501)
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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