RECRUITING

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

Talk to us

Conditions

Osteosarcoma RecurrentEwing's Tumor Recurrent

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-07
Study Completion:2030-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06892678

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.

Ages Eligible for Study:Not specified to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients \< 40 years of age at the time of enrollment
  2. * 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
  3. * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
  4. * Adequate bone marrow function defined as:
  5. * Peripheral absolute neutrophil count (ANC) greater or equal to 750/microliters
  6. * Platelet count greater or equal to 75,000/microliters (transfusion independent)
  7. * Adequate renal function defined by serum creatinine based on age and gender
  8. * Adequate liver function defined as:
  9. * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) for age AND
  10. * SGPT (ALT) ≤ 5.0 x ULN for age. For this study the ULN is 45 U/L
  1. * Pregnant or breastfeeding females
  2. * Patients must not have an uncontrolled infection
  3. * Patients must not have any significant intercurrent illness

Contacts and Locations

Study Contact

Rebecca Zylber, MSN
CONTACT
718-741-2356
rzylber@montefiore.org
Lara Fabish, MSN
CONTACT
718-741-2356
lfabish@montefiore.org

Principal Investigator

Alice Lee, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10467
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • Alice Lee, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-07
Study Completion Date2030-04

Study Record Updates

Study Start Date2025-04-07
Study Completion Date2030-04

Terms related to this study

Additional Relevant MeSH Terms

  • Osteosarcoma Recurrent
  • Ewing's Tumor Recurrent