Study of drug combination therapy for patients with recurrent and primary refractory Ewing Sarcoma
This trial is designed for patients whose cancer has either returned after previous treatment or did not respond to initial therapy. The study tests multiple combinations of chemotherapy medications to find out which works best with the fewest side effects.
Main inclusion criteria:
- Confirmed diagnosis of Ewing sarcoma or Ewing-like sarcoma through tissue examination
- Patients must be at least 2 years old
- Evidence that the disease has progressed during or after treatment
- Adequate kidney function with a specific measurement of 60 ml/min/1.73m² or higher
- Recent imaging tests completed within 4 weeks before starting the trial
- For some treatment groups, heart function must show an ejection fraction of 50% or higher
- Agreement to use effective birth control during treatment and for 12 months afterward
- Female patients who can become pregnant must have a negative pregnancy test
- Ability to receive at least two of the treatment options offered in the study
Main exclusion criteria:
- Patients younger than 6 years or older than 65 years of age
- Patients who have not experienced cancer recurrence or have not shown resistance to initial treatment
- Inability to undergo systemic therapy due to medical reasons
- Severe medical conditions that would make participation unsafe
- Current participation in other clinical trials that might interfere with this study
- Pregnancy or breastfeeding
- Known allergies or sensitivities to the study medications
- Inability to complete required imaging tests or follow-up visits
Trial focus and approach:
The study aims to determine which combination of chemotherapy medications is most effective for treating Ewing sarcoma that has returned or did not respond to initial treatment. Participants will be randomly assigned to different treatment groups, each receiving a specific combination of anti-cancer medications.
The medications being tested include gemcitabine, docetaxel, irinotecan, temozolomide, topotecan, carboplatin, cyclophosphamide, ifosfamide, etoposide, and lenvatinib. These medications work in different ways to stop cancer cells from growing and spreading. Some are given through an intravenous infusion into a vein, while others are taken orally as capsules. The treatment schedule varies depending on which combination a patient receives, with some medications given daily and others on specific days during treatment cycles that typically last several weeks.
Throughout the study, doctors will monitor tumor size using imaging scans performed after 2, 4, and sometimes 6 cycles of treatment. A special type of scan called PET-CT will be done after 4 cycles. The medical team will also closely track any side effects, monitor heart function, liver function, kidney function, and blood pressure regularly. Patients will be asked about their quality of life during treatment.
The total treatment duration may continue for up to 104 weeks, depending on how well the treatment is working. The study measures several important outcomes, including how long patients live without their disease getting worse, overall survival time, and the amount of time patients spend in the hospital.
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