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Clinical Trial NCT01864109 for Newly Diagnosed Ewing Sarcoma is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Memorial Sloan Kettering Cancer CenterIrinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma Phase 2 83 Pediatric
Clinical Trial NCT01864109 is designed to study Treatment for Newly Diagnosed Ewing Sarcoma. It is a Phase 2 interventional study that is active, not recruiting, having started on May 1, 2013, with plans to enroll 83 participants. Led by Memorial Sloan Kettering Cancer Center, it is expected to complete by May 1, 2027. The latest data from ClinicalTrials.gov was last updated on November 12, 2025.
Brief Summary
The purpose of this study is to find out what effects, good and/or bad, the combination of irinotecan and temozolomide has on Ewing sarcoma.
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 ...
Show MoreOfficial Title
A Phase II Trial of Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
Conditions
Newly Diagnosed Ewing SarcomaOther Study IDs
- 13-068
NCT ID Number
Start Date (Actual)
2013-05
Last Update Posted
2025-11-12
Completion Date (Estimated)
2027-05
Enrollment (Estimated)
83
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
CYCLOPHOSPHAMIDE (CYTOXAN)
DOXORUBICIN/ADRIAMYCIN
ETOPOSIDE (VP-16)
IFOSFAMIDE
IRINOTECAN (CPT-11) CAMPTOSAR
TEMOZOLOMIDE
VINCRISTINE
13-068
DOXORUBICIN/ADRIAMYCIN
ETOPOSIDE (VP-16)
IFOSFAMIDE
IRINOTECAN (CPT-11) CAMPTOSAR
TEMOZOLOMIDE
VINCRISTINE
13-068
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPatients 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
* Dox...Show More | 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. |
ExperimentalPatients 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 intravenou...Show More | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
event free survival of patients with localized disease | We will determine event free survival from the time of study entry for all patients. An event would include death from any cause, progression of tumor, recurrence of tumor, or second malignancy.
Progressive disease (PD) will be defined according to RECIST 1.1. | 4 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
event free survival of patients with metastatic disease | We will determine event free survival from the time of study entry for all patients. An event would include death from any cause, progression of tumor, recurrence of tumor, or second malignancy.
Progressive disease (PD) will be defined according to RECIST 1.1. | 4 years |
adverse event profile | Toxicities are graded by the Common Toxicity Criteria (Version 4.0) developed by the National Cancer Institute (NCI) of the USA. | 2 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
1 Year
Eligible Sexes
All
- Age greater than or equal to one year and less than or equal to 40 years at the time of diagnosis
- 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.
- Prior chemotherapy or radiotherapy (other than limited, emergent radiotherapy for treatment of eg. spinal cord compromise or threatened airway)
- Pregnant or breastfeeding females
Memorial Sloan Kettering Cancer Center739 active studies to exploreNo contact data.
7 Study Locations in 1 Countries
New Jersey
Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, 07645, United States
New York
Memorial Sloan Kettering Commack, Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester, Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, 11553, United States