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
Trial Overview
The study tests if adding topotecan hydrochloride to a standard chemotherapy regimen (vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide and etoposide) improves outcomes in Ewing sarcoma patients. Participants are randomly assigned to receive either the standard treatment alone or with the additional drug.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.
INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.
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
Published Research Related to This Trial
Citations
Long-Term Outcomes in Patients With Localized Ewing ...
Patients were randomly assigned to receive vincristine-doxorubicin-cyclophosphamide and ifosfamide-etoposide alternating once every 3 weeks ...
Dose intensity and outcomes of VDC/IE chemotherapy for ...
Dose intensity and outcomes of VDC/IE chemotherapy for adolescent and adult patients with Ewing's family sarcoma. download. Background: Ewing's family sarcoma ( ...
Localized Adult Ewing Sarcoma (ES): Improved Outcomes ...
Localized Adult Ewing Sarcoma (ES): Improved Outcomes With Ifosfamide and Etoposide (IE) Added to Cyclophosphamide, Doxorubicin, and Vincristine (CAV) ...
Addition of Ifosfamide and Etoposide to Standard ...
A new drug combination, ifosfamide and etoposide, was highly effective in patients with Ewing's sarcoma or primitive neuroectodermal tumor of bone who had a ...
Localized Adult Ewing Sarcoma: Favorable Outcomes with ...
This article evaluates outcomes for adults with localized Ewing sarcoma treated exclusively with cyclophosphamide, doxorubicin, and vincristine followed by ...
Phase III Trial Adding Vincristine-Topotecan ...
This trial further validates excellent patient outcomes with interval compressed chemotherapy, a finding also seen in preliminary results comparing interval ...
Efficacy and Safety of the Topotecan–Cyclophosphamide ...
In the first-line treatment of metastatic ES, the addition of ifosfamide and etoposide (IE) to a vincristine, doxorubicin, and cyclophosphamide ...
AEWS1031
Intergroup Ewing sarcoma study INT-0091 (CCG 7881, POG 8850) demonstrated that a regimen of alternating vincristine-doxorubicin-cyclophosphamide and ifosfamide- ...
Outcomes of Pediatric Patients With Metastatic Ewing...
The survival rates of patients with localized ES have increased over time, which is primarily because of the addition of cycles of ifosfamide/etoposide (IE) to ...
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eviq.org.au
eviq.org.au/medical-oncology/sarcoma/bone-sarcoma/1916-ewing-sarcoma-vdc-vincristine-doxorubicin1916-Ewing sarcoma VDC (vinCRISTine, DOXORubicin ...
PURPOSE: Chemotherapy with alternating vincristine-doxorubicin-cyclophosphamide and ifosfamide-etoposide cycles and primary tumor treatment with surgery and/or ...
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