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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

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

Pivotal Trial

No Placebo-Only Group

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have Ewing Sarcoma as a second cancer and haven't had chemo or radiation for my first cancer.

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My cancer has not spread to other parts of my body.

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My cancer did not originate in the brain or spinal cord's protective coverings.

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My cancer has spread to the bones near my joints.

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I have fluid and nodules in the lining of my lung on the opposite side of my cancer.

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My cancer has spread to distant lymph nodes.

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My diagnosis is not Ewing sarcoma.

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

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2310