drugset / Trial / NCT01946529

Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors

NCT01946529

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This protocol will study treatment for Ewing sarcoma family of tumors (ESFT) and desmoplastic small round cell tumor (DSRCT). Participants with ESFT will be divided into two treatment groups, A or B, based on tumor characteristics. Group A (standard risk) participants have tumor that is not in the pelvis, has not spread to other parts of the body, and are less than 14 years of age. Because previous clinical trials have shown that standard treatment is very effective for children whose tumors have these characteristics, these participants will receive standard treatment. Group B (high risk) participants are 14 years of age or older or have tumor in the pelvis, or the tumor has spread to other parts of the body. Participants with DSRCT in the abdomen and/or pelvis or with tumor that cannot be removed by surgery alone or has spread to other parts of the body will be included in Group B. Participants in this group are considered high risk because there is a greater chance of tumor recurring following standard treatments currently in use. All participants will be followed and evaluated for 10 years following completion of therapy.

Timeline

Start
2013-12-27
Primary completion
2015-08
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Comparator Cyclophosphamide Other / unclassified
Comparator Doxorubicin Other / unclassified 2.5 mg/kg Intravenous
Comparator Doxorubicin Other / unclassified 75 mg/m2 Intravenous
Comparator Etoposide Small molecule 3.3 mg/kg Intravenous
Comparator Etoposide Small molecule 100 mg/m2 Intravenous
Comparator Ifosfamide Small molecule 60 mg/kg Intravenous
Comparator Ifosfamide Small molecule 1800 mg/m2 Intravenous
Comparator Sorafenib Small molecule 90 mg/m2 Oral
Comparator Temozolomide Small molecule 100 mg/m2 Oral
Comparator Temsirolimus Small molecule 35 mg/m2 Intravenous
Comparator Vincristine Small molecule 0.05 mg/kg Intravenous
Comparator Vincristine Small molecule 1.5 mg/m2 Intravenous