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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

Conditions
Newly Diagnosed Ewing Sarcoma
Interventions
DRUG

Cyclophosphamide

DEVICE

Doxorubicin

DRUG

Vincristine

DRUG

Ifosfamide

DRUG

Etoposide

PROCEDURE

Surgery

RADIATION

Radiation Therapy*

If local control includes RT, RT should be given concurrently with chemotherapy cycles

DRUG

Temozolomide

DRUG

Irinotecan

DRUG

Mesna

Mesna 2,100 mg/m2 (or 70 mg/kg if \< 10 yrs of age) administered intravenously in concordance with institutional pediatric administration guidelines.

DRUG

Dexrazoxane

Dexrazoxane 375 mg/m2 intravenously over approximately 15-30 minutes and as clinically indicated. To be administered immediately prior to doxorubicin.

DRUG

G-CSF

G-CSF-to be administered after the completion of appropriate chemotherapy cycles as per institutional guidelines.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Commack, Commack

07920

Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01864109 - Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma | Biotech Hunter | Biotech Hunter