This phase II trial studies how well irinotecan hydrochloride, temozolomide, and combination chemotherapy work in treating patients with newly diagnosed Ewing sarcoma. Drugs used in chemotherapy, such as irinotecan hydrochloride, temozolomide, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, or by stopping them from dividing.
Additional locations may be listed on ClinicalTrials.gov for NCT01864109.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the effect on event free survival of irinotecan hydrochloride (irinotecan) and temozolomide added to standard therapy of patients with localized disease.
SECONDARY OBJECTIVES:
I. To estimate the effect on event free survival of irinotecan and temozolomide added to standard therapy of patients with metastatic disease.
II. To determine the tolerability and adverse event profile of irinotecan and temozolomide added to standard therapy.
III. To estimate overall survival with the addition of irinotecan and temozolomide to the initial treatment of patients with Ewing sarcoma (ES).
OUTLINE: Patients are assigned to 1 of 2 treatment groups based on disease stage.
GROUP I (localized disease):
CYCLES 1-3, 7: Patients receive cyclophosphamide intravenously (IV) over 6 hours* and doxorubicin hydrochloride IV over 15-30 minutes* on days 1-2, and vincristine sulfate IV* over 10 minutes on day 1.
CYCLES 4-6: Patients receive ifosfamide IV over 2 hours and etoposide phosphate IV over 1 hour* on days 1-5.
CYCLES 8-13: Patients receive irinotecan hydrochloride IV over 1 hour* on days 1-10 and temozolomide orally (PO) or IV* over 90 minutes at the discretion of treating physician on days 1-5.
Treatment repeats every 3 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity.
GROUP II (metastatic disease):
CYCLES 1-3, 15: Patients receive cyclophosphamide IV over 6 hours* and doxorubicin hydrochloride IV over 15-30 minutes* on days 1-2, and vincristine sulfate IV* over 10 minutes on day 1.
CYCLES 4, 5, 7, 8, 10, 11, 13, 14, 16, and 17: Patients receive irinotecan hydrochloride IV over 1 hour* on days 1-10 and temozolomide PO or IV* over 90 minutes at the discretion of treating physician on days 1-5.
CYCLES 6, 9, and 12: Patients receive ifosfamide IV over 2 hours and etoposide phosphate IV over 1 hour* on days 1-5.
Treatment repeats every 3 weeks for 17 cycles in the absence of disease progression or unacceptable toxicity.
* NOTE: And as clinically indicated.
After completion of study treatment, patients are followed up monthly for 1 year, every 2 months for 1 year, every 4 months for 1 year, and every 6 months for 1 year.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorEmily Kanaya Slotkin
