Study on Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas

Sponsor: Milton S. Hershey Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT06465199

Provider View

This clinical trial is testing a new combination of oral drugs, AMXT 1501 and eflornithine (DFMO), to see if they are safe and effective in treating certain types of cancer in young patients, including neuroblastoma, CNS tumors, and sarcomas.

Patient Parameters

Program Overview

The study aims to find the best dose of the investigational drug AMXT 1501 when used with eflornithine (DFMO) and to test their safety and effectiveness in treating specific cancers. These drugs are not yet approved by the FDA for these conditions. Researchers will look at how patients respond to the treatment and how long they can live without their disease getting worse.

Eligibility Criteria

Inclusion Criteria

  • Must be diagnosed with certain cancers like neuroblastoma, CNS tumors, or sarcomas before age 21.
  • Age requirements vary by study phase:
    • Phase I-AYA: 12 years or older.
    • Phase I-Pediatric: Under 12 years, starting after safety is confirmed in older group.
    • Phase II: 21 years or younger at diagnosis.
  • Must have a confirmed diagnosis of specific tumor types, such as relapsed or refractory neuroblastoma, Ewing sarcoma, or osteosarcoma.
  • Must have undergone disease staging before starting the study.
  • Must have relapsed or refractory disease, meaning the cancer has returned or not responded to previous treatments.
  • Must be able to swallow capsules.
  • Must have stable health conditions if taking steroids for CNS disease.
  • Must have recovered from previous cancer treatments within specific timeframes.
  • Must have a performance score of 60 or higher, indicating the ability to carry out daily activities.
  • Must have adequate organ function, including blood, liver, heart, and kidney health.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Must provide written informed consent to participate.

Exclusion Criteria

  • Body surface area less than 0.25 m2.
  • Currently taking another investigational drug.
  • Currently receiving other cancer treatments.
  • Have an uncontrolled infection.
  • Unable to comply with study requirements or safety monitoring.

Locations

FACILITYZIPCITYSTATE
Penn State Milton S. Hershey Medical Center and Children's Hospital17033HersheyPennsylvania

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