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

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.

Eligibility

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
* Adequate bone marrow function defined as:
* Peripheral absolute neutrophil count (ANC) greater or equal to 750/microliters
* Platelet count greater or equal to 75,000/microliters (transfusion independent)
* Adequate renal function defined by serum creatinine based on age and gender
* 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
* Patients must not have an uncontrolled infection
* Patients must not have any significant intercurrent illness

Conditions3

Locations1 site

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