OncoMatch/Clinical Trials/NCT06465199
Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas
Is NCT06465199 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Other
Cancer type
Tumor Agnostic
Sarcoma
Diffuse Intrinsic Pontine Glioma
Osteosarcoma
Neuroblastoma
Demographics
Prior therapy
Cannot have received: investigational drug
Participants who are currently receiving another investigational drug are excluded from participation.
Cannot have received: anticancer agent
Participants who are currently receiving other anticancer agents are not eligible.
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 equation for <17 years, Cockcroft and Gault formula for ≥17 years)
Liver function
AST and ALT <10x upper limit of normal
Cardiac function
Normal serum Cardiac Troponin Concentration; Normal BNP; QTcF ≤ 470 msec (or EKG with no significant findings); Normal ECHO (Shortening fraction ≥ 27% or Ejection fraction ≥ 50%)
Participants must have adequate organ function at the time of enrollment: Hematological: Hematological recovery as defined by ANC ≥750/μL (unsupported- >24 hrs off G-CSF and 7 days off neulasta); Liver: Adequate liver function as defined by AST and ALT <10x upper limit of normal; Cardiac: all participants must have: 1. Normal serum Cardiac Troponin Concentration 2. Normal BNP (B-type natriuretic peptide) Level 3. A QTcF ≤ 470 msec (or EKG with no significant findings) 4. Normal ECHO defined as: i. Shortening fraction of ≥ 27% by echocardiogram, or ii. Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram; Renal: Participants must have adequate renal function defined as: 1. For participants < 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Bedside Schwartz equation is: [(0.413) X (Height in cm)] / SCr 2. For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Cockcroft and Gault formula is: [(140-age) x (Wt in kg) x (0.85 if female)] / (72 x SCr)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Joseph's Children's Hospital · Tampa, Florida
- Kapiolani Medical Center for Women and Children · Honolulu, Hawaii
- Children's Mercy Hospitals and Clinics · Kansas City, Kansas
- Cardinal Glennon Children's Medical Center · St Louis, Missouri
- 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 →Frequently asked questions
Is NCT06465199 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug, anticancer agent disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 26 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify