OncoMatch/Clinical Trials/NCT06465199
Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas
Is NCT06465199 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Eflornithine (DFMO) and AMXT 1501 Dicaprate for atypical teratoid/rhabdoid tumor.
Treatment: Eflornithine (DFMO) · AMXT 1501 Dicaprate — The purpose of this study is to evaluate the investigational oral drug AMXT 1501 in combination with oral eflornithine (DFMO). An investigational drug is one that has not been approved by the U.S. Food \& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat. The goals of this part of the study are: * Establish a recommended dose of AMXT 1501 in combination with DFMO * Test the safety and tolerability of AMXT 1501 in combination with DFMO * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Diffuse Intrinsic Pontine Glioma
Glioblastoma
Osteosarcoma
Neuroblastoma
Prior therapy
Must have received: multi-drug induction chemotherapy — induction
High-risk neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation, surgery, and immunotherapy, or according to a standard high-risk treatment/neuroblastoma protocol)
Must have received: multi-agent chemotherapy with local control (surgery or radiation)
Standard of care therapy for Ewing sarcoma and osteosarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy
Must have received: standard of care radiation therapy — upfront
Subjects with DIPG to start greater than 30 days, and no longer than 60 days, after standard of care radiation therapy
Lab requirements
Blood counts
ANC ≥750/μL (unsupported- >24 hrs off G-CSF and 7 days off neulasta)
Kidney function
eGFR ≥ 70 mL/min/1.73 m2 (Bedside Schwartz or Cockcroft and Gault formula) or 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2
Liver function
AST and ALT <10x upper limit of normal
Cardiac function
Normal serum Cardiac Troponin, normal BNP, QTcF ≤ 470 msec (or EKG with no significant findings), normal ECHO (shortening fraction ≥ 27% or ejection fraction ≥ 50%)
Hematological: ANC ≥750/μL (unsupported- >24 hrs off G-CSF and 7 days off neulasta); Liver: AST and ALT <10x upper limit of normal; Cardiac: Normal serum Cardiac Troponin, normal BNP, QTcF ≤ 470 msec (or EKG with no significant findings), normal ECHO (shortening fraction ≥ 27% or ejection fraction ≥ 50%); Renal: eGFR ≥ 70 mL/min/1.73 m2 (Bedside Schwartz or Cockcroft and Gault formula) or 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Arkansas Children's Hospital · Little Rock, Arkansas
- Connecticut Children's Hospital · Hartford, Connecticut
- St. Joseph's Children's Hospital · Tampa, Florida
- Kapiolani Medical Center for Women and Children · Honolulu, Hawaii
- Penn State Milton S. Hershey Medical Center and Children's Hospital · Hershey, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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