Study of Eribulin in Children With Cancer to Determine Safety

Lymphoma Clinical Trial

— ERIBULIN  

Official title:

A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02082626
• Other study ID #: 3812
• Status: Terminated
• Phase: Phase 1
• Start date: February 1, 2014
• Est. completion date: June 2018

Study information

• Verified date: March 2020
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Pediatric Cancer
• Solid Tumors

Intervention

Drug:
• Eribulin mesylate

Locations

Country	Name	City	State
United States	Jimmy Everest Center for Cancer and Blood Disorders in Children	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose	The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects	1 year
Secondary	Pharmacokinetics of eribulin in children with cancer	13 blood samples will be drawn from each subject over first 8 days of protocol to measure serum levels of the agent eribulin.	8 days after first dose
Secondary	Tumor expression of BRCP and ABCB1	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	1 year
Secondary	Tumor response	Subjects receiving eribulin will have scans approximately every 6 weeks to assess whether the tumors are growing, shrinking, or remaining stable.	2 years