Study of Eribulin in Children With Cancer to Determine Safety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-01

Study Completion Date

2018-06-30

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.

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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.

Conditions

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Pediatric Cancer Solid Tumors Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eribulin

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

Group Type EXPERIMENTAL

Eribulin mesylate

Intervention Type DRUG

Interventions

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Eribulin mesylate

Intervention Type DRUG

Other Intervention Names

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Halaven

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