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

  • STATUS
    Recruiting
  • End date
    May 13, 2023
  • participants needed
    93
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 13 June 2022

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 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.

Details
Condition Newly Diagnosed Ewing Sarcoma
Treatment G-CSF, cyclophosphamide, etoposide, ifosfamide, Temozolomide, Irinotecan, vincristine, MESNA, doxorubicin, Surgery, Dexrazoxane, Radiation Therapy*
Clinical Study IdentifierNCT01864109
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Prior chemotherapy or radiotherapy (other than limited, emergent radiotherapy for treatment of eg. spinal cord compromise or threatened airway)
Pregnant or breastfeeding females
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