DFMO Maintenance for Patients with Returning or Hard-to-Treat Ewing Sarcoma or Osteosarcoma
Sponsor: Montefiore Medical Center
ClinicalTrials ID:NCT06892678
This study is exploring whether the drug DFMO can be safely given to patients with Ewing sarcoma or osteosarcoma who have had a relapse but currently show no signs of the disease after completing their treatment.
Patient Parameters
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Program Overview
The study aims to find out if DFMO, a drug that has been used in other cancers, can help prevent the return of Ewing sarcoma or osteosarcoma in patients who have already completed their treatment and currently have no evidence of the disease. DFMO has been used in over 100 children with cancer, and its safety and dosage are well understood. This study will focus on patients who have had a relapse of these cancers but are now disease-free after treatment, to see if DFMO can help keep the cancer from coming back.
Description
Ewing sarcoma and osteosarcoma are types of bone cancer that can sometimes return after treatment. About 30-35% of patients with these cancers experience a relapse, which can be very serious. DFMO, also known as eflornithine, is a drug that has been studied in various cancers and is approved by the FDA to help prevent relapse in high-risk neuroblastoma. This study will look at whether DFMO can be used in patients with relapsed Ewing sarcoma or osteosarcoma who have completed their treatment and currently show no signs of cancer, to see if it can help prevent the cancer from coming back. The study will include patients under 40 years old who have finished all their planned therapy and are currently disease-free. DFMO has been given to many children with cancer, so its safety and dosage are well known. The goal is to see if DFMO can improve the chances of staying cancer-free for these patients.
Eligibility Criteria
Inclusion Criteria
- Patients under 40 years old.
- Diagnosed with relapsed Ewing sarcoma or osteosarcoma and have completed all planned treatment for their relapse.
- Currently have no signs of cancer.
- Must be in good general health, with an ECOG performance status of 0, 1, or 2.
- Have adequate bone marrow function, with a neutrophil count of at least 750/microliters and a platelet count of at least 75,000/microliters without needing transfusions.
- Have good kidney function based on specific blood tests.
- Have good liver function, with total bilirubin and liver enzymes within specified limits.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Patients with an uncontrolled infection.
- Patients with any significant ongoing illness.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Montefiore Medical Center | 10467 | Bronx | New York |
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