Study of Eribulin in Children With Cancer to Determine Safety (ERIBULIN)

University of Oklahoma (OU)

Status and phase: Terminated; Phase 1

Conditions: Lymphoma; Pediatric Cancer; Solid Tumors

Treatments: Drug: Eribulin mesylate

Study type: Interventional

Funder types: Other

Identifiers

NCT02082626

3812

Details and patient eligibility

About

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 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.

Enrollment: 3 patients

Sex: All

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Eribulin

Experimental group

Description:

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

Treatment:

Drug: Eribulin mesylate