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Irinotecan + Temozolomide for Ewing Sarcoma

Phase 2

Waitlist Available

Led By Emily Slotkin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed, previously untreated patients with histologically or molecularly confirmed Ewing sarcoma

Adequate renal function: Normal creatinine for age, Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the use of two chemotherapy drugs, irinotecan and temozolomide, in patients with newly diagnosed Ewing sarcoma.

Who is the study for?

This trial is for patients aged 1 to 40 years with newly diagnosed, untreated Ewing sarcoma. They must have normal heart and kidney function, adequate liver function even if the tumor involves the liver, and sufficient blood cell counts. Participants need a central venous catheter and must agree to use contraception if of reproductive potential.

What is being tested?

The study tests adding irinotecan and temozolomide (chemotherapy drugs) to the existing high-dose alkylator-based chemotherapy regimen (EFT), along with surgery/radiation as needed. This combination aims to improve outcomes in patients who are newly diagnosed with Ewing sarcoma.

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, vomiting, hair loss, increased risk of infection due to low blood cell counts, fatigue, diarrhea from irinotecan specifically, and possible damage to organs like the heart or kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been newly diagnosed with Ewing sarcoma and have not received any treatment.

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My kidney function tests are normal.

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My liver tests are within the required limits.

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I was diagnosed with my condition between the ages of 1 and 40.

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My blood tests show normal white cell and platelet counts.

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My heart is functioning well, as confirmed by heart tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years 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 of patients with localized disease

Secondary study objectives

adverse event profile

event free survival of patients with metastatic disease

Awards & Highlights

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: Patients with metastatic diseaseExperimental Treatment12 Interventions

Patients will get 10 cycles of the combination intercalated between the final 4 cycles of standard chemotherapy. * Cycles 4, 5, 7, 8, 10, 11, 13, 14, 16, and 17 will include: * Irinotecan will be given on 10 days over weeks 1 and 2 of a cycle at a dose of 20 mg/m2/day intravenously * Temozolomide will be given daily on the first 5 days of irinotecan administration at a dose of 100 mg/m2/day orally or intravenously * Cycles 6, 9, and 12 will include: * Ifosfamide 2,800 mg/m2/day on days 1-5 * Etoposide 100 mg/m2/day on days 1-5 * Cycle 15 will include: * Cyclophosphamide will be given on days 1 and 2 at a dose of 2,100 mg/m2/day, or for patients \< 10 years of age at a dose of 70 mg/kg/day * Doxorubicin will be given on days 1 and 2 at a dose of 37.5 mg/m2/day * Vincristine will be given on day 1 at a dose of 2 mg/m2 or 0.067 mg/kg (whichever is lower, to a max dose of 2 mg)

Group II: Patients with localized diseaseExperimental Treatment12 Interventions

Patients with localized disease will receive six cycles of the combination as "maintenance" therapy following standard chemotherapy. * Cycles 4-6 will include: * Ifosfamide 2,800 mg/m2/day on days 1-5 * Etoposide 100 mg/m2/day on days 1-5 * Cycle 7 will include : * Cyclophosphamide will be given on days 1 and 2 at a dose of 2,100 mg/m2/day, or for patients \< 10 years of age at a dose of 70 mg/kg/day * Doxorubicin will be given on days 1 and 2 at a dose of 37.5 mg/m2/day * Vincristine will be given on day 1 at a dose of 2 mg/m2 or 0.067 mg/kg (whichever is lower, to a max dose of 2 mg) * Cycles 8-13 will include: * Irinotecan will be given on 10 days over weeks 1 and 2 of a cycle at a dose of 20 mg/m2/day intravenously * Temozolomide will be given daily on the first 5 days of irinotecan administration at a dose of 100 mg/m2/day orally or intravenously

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vincristine

2003

Completed Phase 4

~2970

Cyclophosphamide

2010

Completed Phase 4

~2310