Study of Eribulin in Children With Cancer to Determine Safety
Conditions
Pediatric Cancer - Solid Tumors - Lymphoma
Conditions: Keywords
Phase I, Pediatric, Cancer, Lymphoma, Eribulin
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Eribulin mesylate
Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 20 Years
Minimum Age: N/A
Gender: Both
Criteria: 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
Location
Jimmy Everest Center for Cancer and Blood Disorders in Children
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Rene Y McNall-Knapp, MD - 405-271-4412 - rene-mcnall@ouhsc.edu
Start Date
February 2014
Completion Date
December 2015
Sponsors
University of Oklahoma
Source
University of Oklahoma
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page