← Back to Search

Alkylating agents

Combination Chemotherapy for Ewing Sarcoma

Phase 3
Waitlist Available
Led By Patrick J Leavey
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73 m^2 or serum creatinine based on age/gender
Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue
Must not have
Patients diagnosed with Ewing Sarcoma as a second malignant neoplasm are not eligible if they have received chemotherapy or radiation for the treatment of their primary malignancy
Patients must have no evidence of metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 126 days after enrollment
Awards & highlights

Summary

This trial found that adding the new chemotherapy drug combination to the established treatment approach improved the outcome for patients with extracranial Ewing sarcoma.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include nausea and vomiting from chemotherapy drugs like doxorubicin and cyclophosphamide; hair loss due to vincristine; increased risk of infections from white blood cell reduction; potential heart damage from doxorubicin; and bladder irritation from ifosfamide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney function is normal or near normal.
Select...
I have a new diagnosis of Ewing sarcoma or PNET in my bones or soft tissues.
Select...
I have been diagnosed with Ewing sarcoma or PNET.
Select...
My liver function tests are within normal limits.
Select...
My bilirubin levels are within the normal range for my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have Ewing Sarcoma as a second cancer and haven't had chemo or radiation for my first cancer.
Select...
My cancer has not spread to other parts of my body.
Select...
My cancer did not originate in the brain or spinal cord's protective coverings.
Select...
My cancer has spread to the bones near my joints.
Select...
I have fluid and nodules in the lining of my lung on the opposite side of my cancer.
Select...
My cancer has spread to distant lymph nodes.
Select...
My diagnosis is not Ewing sarcoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-Free Survival
Other study objectives
Histological Response, in Terms of Event Free Survival After Local Control in Patients Who Received Local Control Therapy
Occurrence of Grade 2 or Higher Musculoskeletal Event (ME), or Surgery Required to Treat a Complication of Local Therapy
Overall Survival
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (combination chemotherapy, topotecan hydrochloride)Experimental Treatment8 Interventions
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.
Group II: Arm A (combination chemotherapy)Experimental Treatment7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2960
Cyclophosphamide
2010
Completed Phase 4
~2320
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Ifosfamide
2010
Completed Phase 4
~3140
Topotecan Hydrochloride
2013
Completed Phase 3
~6270
Vincristine Sulfate
2005
Completed Phase 3
~10270
Dexrazoxane
2016
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,188 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,358 Total Patients Enrolled
1 Trials studying Extraskeletal Ewing Sarcoma
1,582 Patients Enrolled for Extraskeletal Ewing Sarcoma
Patrick J LeaveyPrincipal InvestigatorChildren's Oncology Group

Media Library

Extraskeletal Ewing Sarcoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01231906 — Phase 3
~44 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top