Spots Global Cancer Trial Database for Study of Eribulin in Children With Cancer to Determine Safety
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Trial Identification
Brief Title: Study of Eribulin in Children With Cancer to Determine Safety
Official Title: A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors
Study ID: NCT02082626
Interventions
Study Description
Brief Summary: This is a study for children with cancer with no curative treatment options. The investigators will be giving eribulin, a new chemotherapy agent, for the first time to children. This study is designed to determine a safe dose the investigators can give to children in larger studies. The investigators will be monitoring the children on this study for the safety of the treatment and levels of eribulin in the blood after treatment. The investigators will also study the effect of the agent on the cancer.
Detailed Description: This is a phase I study of eribulin, a novel tubulin inhibitor in children with relapsed and refractory solid tumors including lymphoma. Dose escalation will be performed in a classic 3+3 design starting with 75% of the adult maximum tolerated dose (MTD). Pharmacokinetics will be done on each patient. Primary endpoint will be the pediatric MTD.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Jimmy Everest Center for Cancer and Blood Disorders in Children, Oklahoma City, Oklahoma, United States
Contact Details
Name: Rene Y McNall-Knapp, MD
Affiliation: University of Oklahoma
Role: PRINCIPAL_INVESTIGATOR
Name: Amanda Linz, MD
Affiliation: University of Oklahoma
Role: PRINCIPAL_INVESTIGATOR
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