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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 126 days after enrollment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My kidney function is normal or near normal.

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I have a new diagnosis of Ewing sarcoma or PNET in my bones or soft tissues.

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I have been diagnosed with Ewing sarcoma or PNET.

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My liver function tests are within normal limits.

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My bilirubin levels are within the normal range for my age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at study enrollment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-Free Survival

Other outcome measures

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

~2440

Cyclophosphamide

1995

Completed Phase 3

~3780

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Ifosfamide

2010

Completed Phase 4

~2980

Topotecan Hydrochloride

2013

Completed Phase 3

~6120

Vincristine Sulfate

2005

Completed Phase 3

~10110

Dexrazoxane

2016

Completed Phase 2

~80

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,058 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,511 Total Patients Enrolled

Patrick J LeaveyPrincipal InvestigatorChildren's Oncology Group

Media Library

Extraskeletal Ewing Sarcoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01231906 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more positions open for test subjects in this research?

"This particular trial is no longer seeking patients. The listing was created on November 22, 2010 and was last updated on May 19, 2022. However, there are 496 other trials for sarcoma and 1232 trials for Vincristine Sulfate that are still recruiting patients."

Answered by AI

Are there precedents for Vincristine Sulfate's use in treatments?

"Vincristine Sulfate was first evaluated in a 1997 study at Spectrum Health Hospital - Butterworth Campus. To date, there have been 2332 completed trials. Right now, 1232 trials are ongoing, with a high concentration of these taking place in Baltimore, Maryland."

Answered by AI

Have there been any other similar studies done in the past?

"Vincristine Sulfate has been the subject of medical research since 1997. The very first trial was sponsored by Alfacell and took place that same year. It involved 300 patients. After the 1997 trial, Vincristine Sulfate received approval for Phase 3 clinical trials. As of today, there are 1232 active trials for Vincristine Sulfate being conducted in 2671 cities across 74 countries."

Answered by AI

How many subjects are being sought for this research?

"Unfortunately, this clinical trial is not currently looking for patients that fit the requirements. The study was originally posted on 11/22/2010, and the most recent update was on 5/19/2022. If you are interested in other studies, 496 trials for sarcoma and 1232 trials for Vincristine Sulfate are actively recruiting patients."

Answered by AI

Are there different hospitals or care centers conducting this research within the state?

"There are 100 enrolment sites for this clinical trial, such as Sinai Hospital of Baltimore, West virginia University Healthcare, and Siouxland Regional Cancer Center."

Answered by AI

What are some of Vincristine Sulfate's most popular applications?

"Vincristine Sulfate is not only useful for treating lung cancer, but also for small cell lung cancer (sclc), multiple sclerosis, and leukemia, myelocytic, acute."

Answered by AI

Has Vincristine Sulfate completed the necessary steps for approval by the FDA?

"Vincristine Sulfate's Phase 3 status indicates that, while there is data supporting its efficacy, there are multiple rounds of data affirming its safety. Consequently, we have given it a 3."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Phase III Trial Adding Vincristine-topotecan-cyclophosphamide to the Initial Treatment of Patients with Nonmetastatic Ewing Sarcoma: A Children's Oncology Group Report

Leavey, Patrick J., Nadia N. Laack, Mark D. Krailo, Allen Buxton, R. Lor Randall, Steven G. DuBois, Damon R. Reed, et al.. 2021. “Phase III Trial Adding Vincristine-topotecan-cyclophosphamide to the Initial Treatment of Patients with Nonmetastatic Ewing Sarcoma: A Children's Oncology Group Report”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.00358.

Journal of Clinical OncologyJournal

Phase III Trial Adding Vincristine-topotecan-cyclophosphamide to the Initial Treatment of Patients with Nonmetastatic Ewing Sarcoma: A Children's Oncology Group Report

clinicaltrials.govStudy

Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma

2010. "Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01231906.

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