OncoMatch

OncoMatch/Clinical Trials/NCT05717153

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

Is NCT05717153 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Eflornithine and Polyamine Transport Inhibitor AMXT-1501 Dicaprate for diffuse glioma.

Early Phase 1RecruitingMayo ClinicNCT05717153Data as of May 2026

Treatment: Eflornithine · Polyamine Transport Inhibitor AMXT-1501 Dicaprate · MicrodialysisThis 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.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Lab requirements

Blood counts

ANC >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 9 g/dL, all without transfusion within 7 days preceding the lab assessment (obtained <= 14 days prior to registration); aPTT or PTT <= 1.5 x ULN

Kidney function

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)

Liver function

AST and ALT <= 2.5 x ULN; total serum bilirubin <= 1.5 x ULN (obtained <= 14 days prior to registration)

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); aPTT or PTT <= 1.5 x ULN (obtained <= 14 days prior to registration); AST and ALT <= 2.5 x ULN (obtained <= 14 days prior to registration); Total serum bilirubin <= 1.5 x ULN (obtained <= 14 days prior to registration); 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)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Mayo Clinic in Rochester · Rochester, Minnesota

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