drugset / Trial / NCT01864109

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

NCT01864109

Phase 2 Active not recruiting 83 enrolled Memorial Sloan Kettering Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-05
Primary completion
2027-05
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 20 mg/m2 Intravenous
Subject Temozolomide Small molecule 100 mg/m2 Oral
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 70 mg/kg Intravenous
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule 2100 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 70 mg/kg
Background Cyclophosphamide Other / unclassified 2100 mg/m2
Background Dexrazoxane Small molecule 375 mg/m2 Intravenous
Background Etoposide Small molecule 100 mg/m2
Background G-CSF Unknown
Background Ifosfamide Small molecule 2800 mg/m2
Background Vincristine Small molecule 0.067 mg/kg
Background Vincristine Small molecule 2 mg/m2

Indications