Solid Tumor Treatment with Eribulin Mesylate – Phase II

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 evaluating the effects of the drug eribulin mesylate provided to participants suffering from certain types of cancers that have returned or did not respond to standard treatments, specifically rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, and Ewing sarcoma.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting patients, ages 12 months to 18 years, with confirmed rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, or Ewing sarcoma. The age range for participants is 12 months to 18 years.
Males and Females: Ages 12 months to 18 years

Requirements

In 3-week cycles, participants will take the study drug via intravenous infusion on days 1 and 8. During visits for infusions, participants will receive examinations, testing and blood draws. Imaging will also be done at certain intervals. Participants will receive up to 6 cycles of eribulin mesylate, however those who receive a clinical benefit may continue on the study treatment while the study remains active.
Visits: 2 visits for infusions in each 21-day cycle
Duration: 18 weeks (6, 3-week cycles), and possibly longer for patients who benefit from treatment

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1722)
National Cancer Institute
Eisai

Primary Investigator

Andrew Bukowinski, MD, MS

Contact Information

For more information about the study or enrollment, please contact:
Andrew Bukowinski, MD, MS
412-692-5055