Testing a New Combination of Anti-Cancer Drugs for Newly Diagnosed Ewing Sarcoma with Metastasis
Sponsor: Children's Oncology Group
ClinicalTrials ID:NCT06820957
This clinical trial is exploring whether a new combination of drugs can improve treatment outcomes for patients newly diagnosed with Ewing Sarcoma or similar cancers that have spread to other parts of the body.
Patient Parameters
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Program Overview
This study is testing a new combination of drugs to see if it works better than the usual treatment for Ewing Sarcoma and similar cancers that have spread. The new treatment includes vincristine, irinotecan, and regorafenib (VIrR) along with the standard drugs vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide, and etoposide (IE). These drugs work by stopping cancer cells from growing and dividing, and they may also kill the cancer cells. The study aims to find out if this new combination can help patients live longer without the cancer getting worse and if it is safe to use.
Description
The main goal of this study is to see if patients with newly diagnosed metastatic Ewing Sarcoma live longer without the cancer getting worse when treated with the new drug combination (VIrR) after initial treatment with standard drugs (VDC/IE), compared to just using the standard drugs.
Other goals include comparing overall survival rates, understanding the side effects of the new treatment, and seeing if higher doses of radiation therapy are safe and effective for large tumors. The study will also look at whether certain DNA markers in the blood can predict how well the treatment works.
The study is divided into different phases:
- Induction Phase: Patients receive a series of chemotherapy drugs over several cycles, followed by surgery or radiation therapy.
- Consolidation Phase I: More chemotherapy cycles are given to continue fighting the cancer.
- Consolidation Phase II: Patients are divided into two groups. One group continues with the standard treatment, while the other group receives the new drug combination (VIrR).
Throughout the study, patients will have regular tests and scans to monitor their health and the cancer's response to treatment. After completing the study treatment, patients will have follow-up visits to check on their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be enrolled in a related study and consent to participate.
- Age between 12 months and 50 years.
- Newly diagnosed with Ewing Sarcoma or similar round cell sarcomas.
- Must have cancer that has spread to distant parts of the body.
- Must meet specific health criteria, including kidney and liver function, and heart health.
- HIV-positive patients can participate if their viral load is undetectable.
- Must agree to use effective birth control during and after the study if of childbearing potential.
Exclusion Criteria
- Cancer that has only spread to nearby lymph nodes.
- Primary tumors in the brain or spinal cord.
- Certain genetic conditions like Charcot-Marie-Tooth disease.
- Previous surgery without proper imaging before surgery.
- Prior chemotherapy or radiation for the current diagnosis.
- Previous treatment with certain cancer drugs.
- History of organ transplant.
- Allergies to regorafenib.
- Active hepatitis B or C.
- Use of certain medications that affect drug metabolism.
- Pregnant or breastfeeding women.
- Must agree to use birth control if of childbearing potential.
- Must sign informed consent to participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| Kapiolani Medical Center for Women and Children | 96826 | Honolulu | Hawaii |
| Lurie Children's Hospital-Chicago | 60611 | Chicago | Illinois |
| Saint Jude Midwest Affiliate | 61637 | Peoria | Illinois |
| NYU Langone Hospital - Long Island | 11501 | Mineola | New York |
| Saint Christopher's Hospital for Children | 19134 | Philadelphia | Pennsylvania |
| Prisma Health Richland Hospital | 29203 | Columbia | South Carolina |
| BI-LO Charities Children's Cancer Center | 29605 | Greenville | South Carolina |
| East Tennessee Childrens Hospital | 37916 | Knoxville | Tennessee |
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