M0 Medulloblastoma Treatment in Very Young Children – Phase I

ADVL1314: Study of Eribulin Mesylate, a Novel Microtubule Targeting Chemotherapeutic Agent, in Children with Refractory or Recurrent Solid Tumors including Lymphomas

Protocol Description

This multicenter trial by the Children’s Oncology Group studies the effects of eribulin mesylate for solid tumors and lymphomas that do not respond to other treatment or which have come back after treatment.

Study Level: Phase I

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders from ages 6 months to 17 years, with refractory or recurrent solid tumors or lymphomas, excluding central nervous system tumors. Patients must have had histologic-verification of malignancy at original diagnosis or relapse and their current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
Males and Females: 6 months to 17 years old


Participants will receive the study drug intravenously on days 1 and 8 of 21-day cycles.
Visits: 2 for each cycle of therapy with evaluations at the end of cycle 1, then evaluations every other cycle for 2 cycles, then every 3 cycles.
Duration: Varies according to treatment response

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ADVL1314)
National Cancer Institute
Eisai Inc.

Primary Investigator

Gary Mason, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator Angela Connelly, RN, BSN