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New treatment option for Metastatic Ewing Sarcoma
Official title Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes
ClinicalTrials.gov ID: NCT07194044
What this study is testing
What is Vincristine?
Vincristine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic ewing sarcoma.
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
- This single arm study is designed to demonstrate the feasibility of a radically different approach for an exceptionally high-risk subset of MES with widely metastatic disease (WMES). We incorporate the use of evolutionary principles that apply to species and population dynamics as related to adaptation and extinction to populations of cancer cells that similarly adapt and that we are attempting to make extinct, resulting in a cure for the patient.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- Patients must be \>1 year of age. There is no upper age limit.
- Patients, in the opinion of the enrolling investigator, must be healthy enough to tolerate protocol therapy.
- Patients must have a new histologic diagnosis of either: widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma.
- Patients must have sufficient tissue submitted (flash frozen tissue, FFPE block, or up to 10 unstained FFPE slides) for correlative testing. This may...
- Patients must not have received any prior systemic therapy with the exception that they may have started an initial cycle of...
You likely can't join if
- Patients with localized disease or lung only metastases for Ewing sarcoma or localized disease for CIC-rearranged sarcomas.
- Patients with central nervous system (CNS) tumors (primary or metastatic) are not eligible.
- Patients who are receiving any other investigational agents for their cancer.
- Patients with a history of cancer that was treated with myelosuppressive chemotherapy or radiation therapy.
- Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer.
- Patients are ineligible if they have uncontrolled intercurrent illness.
See the full eligibility criteria
- Patients must be \>1 year of age. There is no upper age limit.
- Patients, in the opinion of the enrolling investigator, must be healthy enough to tolerate protocol therapy.
- Patients must have a new histologic diagnosis of either: widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma.
- Patients must have sufficient tissue submitted (flash frozen tissue, FFPE block, or up to 10 unstained FFPE slides) for correlative testing. This may be from a primary or metastatic site.
- Patients must not have received any prior systemic therapy with the exception that they may have started an initial cycle of vincristine/doxorubicin/cyclophosphamide (VDC) prior to enrollment, i.e. VDC may have been...
- Adequate organ function.
- Males and females of reproductive potential may not participate unless they have agreed to the use of, at minimum, two methods of contraception during and after treatment or abstinence.
- All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.
- Patients with localized disease or lung only metastases for Ewing sarcoma or localized disease for CIC-rearranged sarcomas.
- Patients with central nervous system (CNS) tumors (primary or metastatic) are not eligible.
- Patients who are receiving any other investigational agents for their cancer.
- Patients with a history of cancer that was treated with myelosuppressive chemotherapy or radiation therapy.
- Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer.
- Patients are ineligible if they have uncontrolled intercurrent illness.
- Pregnancy or Breast Feeding: Pregnant or breast-feeding women will not be entered on this study, because there is no available information regarding human fetal or teratogenic toxicities. Females of childbearing...
- Patients who are considered unable to comply with the safety monitoring requirements of the study are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Hartford, Connecticut, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Lexington, Kentucky, United States
- Grand Rapids, Michigan, United States
- Buffalo, New York, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, 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, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Hartford, Connecticut, United States; Gainesville, Florida, United States; Jacksonville, Florida, United States; Miami, Florida, United States and 11 more location(s). 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.