Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT07321912
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ewing Sarcoma
  • Ewing Sarcoma Metastatic
  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
0 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Eflornithine — DRUG
    Oral twice daily
  • Topotecan — DRUG
    IV
  • Cyclophosphamide — DRUG
    IV
  • Vincristine — DRUG
    IV
  • Doxorubicin — DRUG
    IV
  • Ifosfamide — DRUG
    IV
  • Etoposide — DRUG
    IV
  • Cisplatin — DRUG
    IV
  • Methotrexate — DRUG
    IV

Study Details

Ewing sarcoma (EWS) and osteosarcoma primarily affect adolescents and young adults. Common treatments include chemotherapy, surgery and radiation, however, there have been few recent advancements in the standard of care. By incorporating eflornithine (DFMO) as an additional therapy and/or maintenance therapy we hope to safely observe improved event-free survival and overall survival. There are 5 cohorts covered under this master protocol.

Key Dates

Start date
May 21, 2026
Status verified
May 2026
Primary completion
Apr 1, 2031
Completion
Apr 1, 2036

Study Design

Enrollment
406 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Relapsed or Refractory Ewing Sarcoma Eligible to Receive Local Control
    DFMO will be administered as concurrent therapy during treatment of Ewing sarcoma. Participants completing treatment without experiencing an analytic event will continue to receive DFMO monotherapy as a maintenance treatment for an additional 24 months.
  • Experimental: Cohort 2: Ewing Sarcoma Patients who are Metastatic at Diagnosis
    DFMO will be administered as concurrent therapy during consolidation treatment of metastatic Ewing sarcoma. Participants completing consolidation treatment without experiencing an analytic event will continue to receive DFMO monotherapy as a post consolidation maintenance treatment for an additional 24 months.
  • Experimental: Cohort 3: Osteosarcoma with relapse in the lung after resection of lung metastases
    DFMO will be dosed twice daily for 730 days.
  • Experimental: Cohort 4A: Osteosarcoma with Poor Response to Induction Therapy at Completion of Local Control
    DFMO will be administered as concurrent therapy during Cycles 4-6 of post-surgery consolidation. Participants completing MAP without experiencing an analytic event will continue to receive DFMO monotherapy as a post consolidation maintenance treatment for an additional 24 months.
  • Experimental: Cohort 4B: Osteosarcoma with Metastatic Disease at Diagnosis at Completion of Local Control
    DFMO will be administered as concurrent therapy during Cycles 4-6 of post-surgery consolidation. Participants completing MAP without experiencing an analytic event will continue to receive DFMO monotherapy as a post consolidation maintenance treatment for an additional 24 months.

Primary Outcome Measure

Number of Cohort 1 participants with relapse free survival (RFS) during study [ Time Frame: 2 years plus 5 years follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Milton S. Hershey Medical Center and Children's HospitalHersheyPennsylvania17033
Penn State Clinical Trials Group Email
[email protected]
Valerie Brown, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Penn State Milton S. Hershey Medical Center and Children's Hospital· Hershey, PA

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