Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma

Inclusion Criteria

• •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.