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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Jimmy Everest Center for Cancer and Blood Disorders in Children
Oklahoma City, Oklahoma, United States
Maximum tolerated dose
The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects
Time frame: 1 year
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.
Time frame: 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
Time frame: 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.
Time frame: 2 years
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