Combination Chemotherapy for Ewing Sarcoma
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to determine if adding a new chemotherapy drug, topotecan hydrochloride, to a standard 5-drug treatment improves outcomes for individuals with Ewing sarcoma, a type of bone or soft tissue cancer that hasn't spread. Participants are divided into two groups: one receives the standard treatment, while the other receives the standard treatment plus topotecan hydrochloride. The trial seeks individuals with newly diagnosed, non-metastatic Ewing sarcoma or related tumors who have not yet received other cancer treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking cancer treatment advancements.
Do I need to stop my current medications to join the trial?
The trial does not specify whether you need to stop taking your current medications. However, since no prior chemotherapy or radiation therapy is allowed, you may need to discuss your current medications with the trial team to ensure they don't conflict with the study requirements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the usual chemotherapy for Ewing sarcoma, which includes drugs like vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide, is generally well-tolerated. Studies have found this treatment effective and less harmful compared to other options. People of different ages have tolerated these drugs well, although side effects can occur.
Adding topotecan to the treatment has shown promising results in studies. This combination has proven effective with manageable side effects. Patients receiving this treatment have also experienced good outcomes. However, like any chemotherapy, side effects can occur, and individuals may react differently.
In summary, both treatment plans have been extensively studied and are considered safe, with side effects that can usually be managed. It's always important to discuss any concerns with healthcare providers.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these combination chemotherapy treatments for Ewing sarcoma because they integrate topotecan hydrochloride, which is not typically part of standard regimens. Unlike traditional treatments, which primarily rely on drugs like vincristine, doxorubicin, and cyclophosphamide, one unique arm in this study also incorporates topotecan, potentially enhancing the treatment's effectiveness. Additionally, the strategic pairing with dexrazoxane aims to reduce heart-related side effects, a concern with doxorubicin usage. This innovative approach could offer improved outcomes and better manage the condition's challenges.
What evidence suggests that this trial's treatments could be effective for Ewing sarcoma?
In this trial, patients with localized Ewing sarcoma will receive one of two combination chemotherapy regimens. Arm A includes vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide, which previous studies have shown to effectively control the disease and extend patient survival. Arm B adds topotecan to this combination, and earlier research suggests that this addition may further enhance patient outcomes. The trial evaluates these chemotherapy combinations as strong options for treating Ewing sarcoma.678910
Who Is on the Research Team?
Patrick J Leavey
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
This trial is for patients with a new diagnosis of non-metastatic Ewing sarcoma or PNET located outside the brain, without prior treatment. Eligible participants must have proper kidney function, normal bilirubin levels, acceptable liver enzyme counts, and good heart function. Pregnant or breastfeeding women are excluded, as well as those who've had previous cancers treated with chemo or radiation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Patients receive a combination of chemotherapy drugs including vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, with additional topotecan hydrochloride in Arm B.
Consolidation Therapy
Continuation of chemotherapy with vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, with additional topotecan hydrochloride in Arm B.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Doxorubicin Hydrochloride
- Etoposide
- Ifosfamide
- Topotecan Hydrochloride
- Vincristine Sulfate
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator