NCT06892678

DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 39 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the feasibility of administering DFMO to patients with relapsed Ewing sarcoma and osteosarcoma who have completed all planned therapy and have no evidence of disease.

Detailed description

Approximately 30-35% of patients diagnosed with osteosarcoma or Ewing sarcoma will develop relapsed/refractory disease and carry a very poor prognosis. DL-alpha-difluoromethylornithine, commonly known as DFMO or eflornithine, is a synthetic analog of the amino acid ornithine. DFMO has been studied in a number of different cancers as either a therapeutic or a chemopreventative agent and is now FDA approved to reduce the risk of relapse in patients with newly diagnosed high-risk neuroblastoma. As DFMO has now been given to over 100 children with metastatic cancer, dosing and safety in this population is well established. Given the stagnant survival rates for children, adolescents, and young adults with relapsed Ewing sarcoma and osteosarcoma over the past few decades, this study will explore the feasibility of using DFMO in patients with relapsed osteosarcoma and relapsed Ewing sarcoma who are without any evidence of disease at the end of therapy in order to prevent disease recurrence.

Conditions

• Osteosarcoma Recurrent
• Ewing's Tumor Recurrent

Interventions

Type	Name	Description
DRUG	DFMO	DFMO dose will be calculated based on the BSA measured within 14 days prior to the beginning of each cycle. Tablets may be swallowed whole, chewed, or crushed and mixed with soft food or liquid.

Timeline

• Start date: 2025-04-07
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2025-03-25
• Last updated: 2025-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study