Study of Eribulin in Children With Cancer to Determine Safety

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pediatric Cancer, Solid Tumors, Lymphoma

Intervention / Treatment
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* Drug: Eribulin mesylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eribulin<br>All patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients. | Drug: Eribulin mesylate<br> <br> * Other names: Halaven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Pediatric, Cancer, Lymphoma, Eribulin