Lymphoma, Pediatric Cancer, Solid Tumors
Conditions
Keywords
Phase I, Pediatric, Cancer, Lymphoma, Eribulin
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.
Interventions
DRUGEribulin mesylate
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Outcome results
None listed