Using DFMO to prevent relapse in patients with Ewing sarcoma or osteosarcoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility of administering DFMO, a synthetic analog of the amino acid ornithine, to patients under 40 years old who have relapsed Ewing sarcoma or osteosarcoma and have completed all planned therapy without evidence of disease. DFMO has been previously used in various cancers and is FDA approved for reducing relapse risk in high-risk neuroblastoma. The study will focus on determining the safety and potential effectiveness of DFMO in preventing disease recurrence in this high-risk population. Approximately 30-35% of patients with these conditions experience relapse, highlighting the need for new preventative strategies.

Why it matters

Who can join: the full rules

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

Where it's running

• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Alice Lee, MD — Montefiore Medical Center
• Study coordinator: Rebecca Zylber, MSN
• Email: rzylber@montefiore.org
• Phone: 718-741-2356

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.