Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
NCT ID: NCT01864109
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
83 participants
INTERVENTIONAL
2013-05-31
2027-05-31
Brief Summary
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Irinotecan and temozolomide are chemotherapy drugs that are used very often to treat pediatric patients at MSKCC. The investigators have used these two drugs for many years to treat patients with Ewing sarcoma whose cancer has relapsed.
For patients with newly diagnosed Ewing sarcoma the current standard of care at MSKCC is a five drug chemotherapy regimen in combination with surgery and/or radiation therapy. This standard regimen is called the EFT regimen. . Some patients with Ewing sarcoma do not have their cancer cured by the chemotherapy and surgery/radiation therapy.
This study adds the chemotherapy drugs called irinotecan and temozolomide to the standard EFT regimen. The investigators are trying to improve the success of standard therapy by adding these drugs. The use of irinotecan and temozolomide in this study is experimental because they have not been used before in patients with newly diagnosed Ewing sarcoma. However the investigators have found these drugs to be effective in patients with relapsed Ewing sarcoma. It is not known if adding these two drugs will improve the outcomes of patients treated for Ewing sarcoma.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients with localized disease
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
Cyclophosphamide
Doxorubicin
Vincristine
Ifosfamide
Etoposide
Surgery
Radiation Therapy*
If local control includes RT, RT should be given concurrently with chemotherapy cycles
Temozolomide
Irinotecan
Mesna
Mesna 2,100 mg/m2 (or 70 mg/kg if \< 10 yrs of age) administered intravenously in concordance with institutional pediatric administration guidelines.
Dexrazoxane
Dexrazoxane 375 mg/m2 intravenously over approximately 15-30 minutes and as clinically indicated. To be administered immediately prior to doxorubicin.
G-CSF
G-CSF-to be administered after the completion of appropriate chemotherapy cycles as per institutional guidelines.
Patients with metastatic disease
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)
Cyclophosphamide
Doxorubicin
Vincristine
Ifosfamide
Etoposide
Surgery
Radiation Therapy*
If local control includes RT, RT should be given concurrently with chemotherapy cycles
Temozolomide
Irinotecan
Mesna
Mesna 2,100 mg/m2 (or 70 mg/kg if \< 10 yrs of age) administered intravenously in concordance with institutional pediatric administration guidelines.
Dexrazoxane
Dexrazoxane 375 mg/m2 intravenously over approximately 15-30 minutes and as clinically indicated. To be administered immediately prior to doxorubicin.
G-CSF
G-CSF-to be administered after the completion of appropriate chemotherapy cycles as per institutional guidelines.
Interventions
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Cyclophosphamide
Doxorubicin
Vincristine
Ifosfamide
Etoposide
Surgery
Radiation Therapy*
If local control includes RT, RT should be given concurrently with chemotherapy cycles
Temozolomide
Irinotecan
Mesna
Mesna 2,100 mg/m2 (or 70 mg/kg if \< 10 yrs of age) administered intravenously in concordance with institutional pediatric administration guidelines.
Dexrazoxane
Dexrazoxane 375 mg/m2 intravenously over approximately 15-30 minutes and as clinically indicated. To be administered immediately prior to doxorubicin.
G-CSF
G-CSF-to be administered after the completion of appropriate chemotherapy cycles as per institutional guidelines.
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed, previously untreated patients with histologically or molecularly confirmed Ewing sarcoma
* Adequate hematologic function:
* Absolute neutrophil count ≥ 1,000/K/mcl
* Platelet count ≥ 100,000/Kmcl
* Adequate renal function:
* Normal creatinine for age (See table below) OR
* Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 Age(Years) Maximum Serum Creatinine (mg/dL) ≤ 5 0.8 6 to ≤ 10 1 11 to ≤ 15 1.2 ≥ 16 1.5
Adequate hepatic function:
* Total bilirubin ≤ 1.5 x the ULN
* AST ≤ 2.5 x the ULN \[in the absence of hepatic involvement of tumor. Patients with hepatic involvement are considered eligibile for study\]
* ALT ≤ 2.5 x the ULN \[in the absence of hepatic involvement of tumor. Patients with hepatic involvement are considered eligibile for study\]
Normal cardiac function:
* Shortening fraction ≥ 28% by echocardiogram OR
* Left ventricular ejection fraction (LVEF) ≥ 50% on technetium- 99m pertechnetate radionuclide cineangiography (MUGA) or echocardiogram
* Patients must consent to an indwelling central venous catheter.
* Sexually active patients of reproductive potential must be willing to use an effective method of contraception.
Exclusion Criteria
* Pregnant or breastfeeding females
1 Year
40 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Emily Slotkin, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Countries
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Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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13-068
Identifier Type: -
Identifier Source: org_study_id