Study of Eribulin in Children With Cancer to Determine Safety

Overview

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.

Full Title of Study: “A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2018

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.

Interventions

  • Drug: Eribulin mesylate

Arms, Groups and Cohorts

  • Experimental: Eribulin
    • All patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients.

Clinical Trial Outcome Measures

Primary Measures

  • Maximum tolerated dose
    • Time Frame: 1 year
    • The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects

Secondary Measures

  • Pharmacokinetics of eribulin in children with cancer
    • Time Frame: 8 days after first dose
    • 13 blood samples will be drawn from each subject over first 8 days of protocol to measure serum levels of the agent eribulin.
  • Tumor expression of BRCP and ABCB1
    • Time Frame: 1 year
    • Archival tumor samples from each subject will be stained for expression of BRCP and ABCB1, transporter proteins responsible for some resistance to chemotherapy. Will compare expression and response data
  • Tumor response
    • Time Frame: 2 years
    • Subjects receiving eribulin will have scans approximately every 6 weeks to assess whether the tumors are growing, shrinking, or remaining stable.

Participating in This Clinical Trial

Inclusion Criteria

  • Age: ≤ 21 years of age at the time of study enrollment – Diagnosis: refractory or recurrent solid tumors, including lymphomas, except those with CNS tumors or known CNS metastases – Disease Status: measurable or evaluable disease – Adequate organ function as defined in protocol Exclusion Criteria:

  • Pregnant or breastfeeding

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 20 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Oklahoma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rene Y McNall-Knapp, MD, Principal Investigator, University of Oklahoma
    • Amanda Linz, MD, Principal Investigator, University of Oklahoma

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