Recruiting
Phase 1
Phase 2

DFMO

Sponsor:

Montefiore Medical Center

Code:

NCT06892678

Conditions

Osteosarcoma Recurrent

Ewing's Tumor Recurrent

Eligibility Criteria

Sex: All

Age: 0 - 39

Healthy Volunteers: Not accepted

Interventions

DFMO

Study Details

Brief summary:

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.

Conditions

Osteosarcoma Recurrent

Ewing's Tumor Recurrent

Study ID

NCT06892678

Start date

Apr 7, 2025

Status verified date

May, 2026

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients < 40 years of age at the time of enrollment
  • Diagnosis of relapsed osteosarcoma or relapsed Ewing sarcoma who have completed all planned therapy for their relapse, as described in the protocol, and have no evidence of disease
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
  • Myelosuppressive chemotherapy: At least 14 days must have elapsed since completion of myelosuppressive therapy
  • Monoclonal antibodies: At least 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade < 2
  • Biologic therapy (defined as anti-cancer agents not known to be myelosuppressive): At least 7 days after the last dose of agent
  • Radiation therapy: At least 14 days must have elapsed after local External Beam Radiation Therapy (XRT), at least 90 days after Total Body Irradiation (TBI), craniospinal XRT or if radiation to greater than 50% of the pelvis, and at least 42 days if other substantial bone marrow radiation
  • Adequate bone marrow function defined as:
  • Peripheral absolute neutrophil count (ANC) greater or equal to 750/microliter
  • Platelet count greater or equal to 75,000/microliter (transfusion independent)
  • Adequate renal function defined by serum creatinine based on age and gender (see protocol)
  • Adequate liver function defined as:
  • Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) for age AND
  • SGPT (ALT) ≤ 5.0 x ULN for age. For this study the ULN is 45 U/L

Exclusion Criteria:

  • Pregnant or breastfeeding females. Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study. Based on the teratogenic potential of the agent, pregnant women will be excluded from this study. Because of potential risks to breastfed infants due to drug metabolites that could be excreted in breast milk, female patients who are lactating must agree to stop breastfeeding or will otherwise be excluded from this study. Females of childbearing potential must have a negative pregnancy test to be eligible for this study
  • Patients must not have an uncontrolled infection
  • Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Rebecca Zylber, MSN

718-741-2356rzylber@montefiore.org

Lara Fabish, MSN

718-741-2356lfabish@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Rebecca Zylber

718-741-2356rzylber@montefiore.org

Lara Fabish

lfabish@montefiore.org

Principal Investigator:

Alice Lee, MD

More Information

Sponsor

Montefiore Medical Center

Last update posted

May 14, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-05-14.