Study of Eribulin in Children With Cancer to Determine Safety
- Registration Number
- NCT02082626
- Lead Sponsor
- University of Oklahoma
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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
- Pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Eribulin Eribulin mesylate All patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients.
- Primary Outcome Measures
Name Time Method Maximum tolerated dose 1 year The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects
- Secondary Outcome Measures
Name Time Method Tumor response 2 years Subjects receiving eribulin will have scans approximately every 6 weeks to assess whether the tumors are growing, shrinking, or remaining stable.
Pharmacokinetics of eribulin in children with cancer 8 days after first dose 13 blood samples will be drawn from each subject over first 8 days of protocol to measure serum levels of the agent eribulin.
Tumor expression of BRCP and ABCB1 1 year 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
Trial Locations
- Locations (1)
Jimmy Everest Center for Cancer and Blood Disorders in Children
🇺🇸Oklahoma City, Oklahoma, United States