Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

Sponsor: Milton S. Hershey Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT07321912

Provider View

This study is exploring the use of eflornithine (DFMO) as an additional or maintenance therapy for Ewing sarcoma and osteosarcoma, which mainly affect young people. The goal is to see if this treatment can improve survival rates when added to standard treatments like chemotherapy, surgery, and radiation.

Patient Parameters

Program Overview

Ewing sarcoma and osteosarcoma are cancers that mostly affect teenagers and young adults. Standard treatments include chemotherapy, surgery, and radiation, but there haven't been many new developments recently. This study is testing whether adding eflornithine (DFMO) can help patients live longer without the cancer coming back. The study includes five different groups of patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 50 years old or younger.
  • Have Ewing sarcoma that has come back or not responded to treatment.
  • Cancer must be treatable with surgery or radiation after the second cycle of treatment.
  • Can join during the first or second cycle of treatment if receiving the same treatment as outlined in the study.
  • Must have at least one of the following signs of cancer:
    • Tumor visible on CT or MRI
    • Positive FDG-PET scan
    • Positive bone marrow biopsy
  • Must have good kidney function.
  • Must have good liver function.
  • Must have good heart function.
  • Must have recovered from previous chemotherapy effects.
  • Must have a performance score of 60 or higher.
  • Women who can have children must test negative for pregnancy and agree to use birth control.
  • Must provide written consent to participate.

Exclusion Criteria

  • Body surface area less than 0.25 m2.
  • Current central nervous system disease.
  • Currently taking another investigational drug.
  • Currently taking other cancer treatments.
  • Have an uncontrolled infection.
  • May not be able to follow study requirements.

Locations

FACILITYZIPCITYSTATE
St. Joseph's Children's Hospital33614TampaFlorida
Penn State Milton S. Hershey Medical Center and Children's Hospital17033HersheyPennsylvania

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