Status:
ACTIVE_NOT_RECRUITING
Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Newly Diagnosed Ewing Sarcoma
Eligibility:
All Genders
1-40 years
Phase:
PHASE2
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 ar...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Prior chemotherapy or radiotherapy (other than limited, emergent radiotherapy for treatment of eg. spinal cord compromise or threatened airway)
- Pregnant or breastfeeding females
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2027
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01864109
Start Date
May 1 2013
End Date
May 1 2027
Last Update
November 12 2025
Active Locations (7)
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1
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725