BridgeMD
New treatment option for Osteosarcoma Recurrent
Official title DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma
ClinicalTrials.gov ID: NCT06892678
What this study is testing
What is DFMO?
DFMO is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for osteosarcoma recurrent.
Also referred to as Difluoromethylornithine, iWilfin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the feasibility of administering DL-alpha-difluoromethylornithine (DFMO) to patients with relapsed Ewing sarcoma and osteosarcoma who have completed all planned therapy and have no evidence of disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 39
You may be able to join if
- 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...
- 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...
You likely can't join if
- Pregnant or breastfeeding females. Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled...
- 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...
See the full 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
- 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...
- 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
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.