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

Conditions

• Ewing's Tumor Recurrent
• Osteosarcoma Recurrent

Eligibility Criteria

Sex

ALL

Age

N/A - 39 Years

Healthy Volunteers

Not accepted

Interventions

• DFMO — DRUG
  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.

Study Details

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

Key Dates

Start date

Apr 7, 2025

Status verified

May 2026

Primary completion

Apr 30, 2030

Completion

Apr 30, 2030

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment with DFMO
  DFMO will be administered orally every 12 hours in 28-day cycles at the FDA approved dosages based on the patient's body surface area (BSA). DFMO tablets are 192 mg. * Patients with a BSA \< 1.5 m\^2 will take 768 mg (four tablets) orally twice a day. * Patients with a BSA 0.75 to 1.5 m\^2 will take 576 mg (three tablets) orally twice a day. * Patients with a BSA of 0.5 to \< 0.75 m\^2 will take 384 mg (two tablets) orally twice a day. * Patients with a BSA of 0.25 to \< 0.5 m\^2 will take 192 mg (one tablet) orally twice a day.

Primary Outcome Measure

Feasibility of Administering DFMO [ Time Frame: Up to 2 years ]

Central Contacts

• Rebecca Zylber, MSN
  718-741-2356
  [email protected]
• Lara Fabish, MSN
  718-741-2356
  [email protected]

Locations (1)

Find similar trials in The Bronx, NY

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