Solid Tumor Treatment with Eribulin Mesylate – Phase II

ADVL1722: Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Subjects with Relapsed/Refractory Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma, and Ewing Sarcoma

Protocol Description

Through this multi-center Children’s Oncology Group study, researchers are investigating the potential of eribulin mesylate for treatment of certain cancers in children and adolescents. Specifically researchers will evaluate eribulin mesylate used in treatment of rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and Ewing sarcoma (EWS) that has either come back or is not responding to treatment.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling pediatric patients who have been diagnosed with relapsed or refractory RMS, NRSTS and EWS.
Boys and Girls: 1 through 17 years of age

Requirements

In 21-day cycles, study participants will receive a specified dose of eribulin mesylate intravenously on days 1 and 8. Additional testing, including blood work and physical examinations, will be done during study visits. Participants can remain in the study unless their condition worsens or side effects are determined to be harmful. Participants will continue to be followed by the study team for up to 1 year after stopping the study medication.
Visits: On days 1 and 8 of each treatment cycle
Duration: Open-ended, providing participants are tolerating the drug, have improved or stable disease, and that it is in their best interest to continue

Status: Open to Enrollment

Source(s) of Support

Eisai, Inc.
Children’s Oncology Group (ADVL1722)

Primary Investigator

Andrew Bukowinski, MD

Contact Information

For more information about the study or enrollment, please contact:
Sharon Dibridge, Clinical Research Coordinator
412-692-7070