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

Status:	Recruiting
Healthy:	No
Age Range:	1 - 40
Updated:	10/20/2018
Start Date:	May 2013
End Date:	May 2020
Contact:	Paul Meyers, MD
Phone:	212-639-5952

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

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.

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

We found this trial at

sites

Memorial Sloan Kettering Monmouth

Middletown, New Jersey 07748

Phone: 212-639-5952

from

Middletown, NJ