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

Description

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.

Conditions

Osteosarcoma Recurrent, Ewing's Tumor Recurrent

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Osteosarcoma Recurrent
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Pregnant or breastfeeding females
  • * Patients must not have an uncontrolled infection
  • * Patients must not have any significant intercurrent illness

Ages Eligible for Study

to 39 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Montefiore Medical Center,

Alice Lee, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

2030-04