Back to resultsStudy of Eribulin in Children With Cancer to Determine Safety (ERIBULIN)
Primary Purpose
Pediatric Cancer, Solid Tumors, Lymphoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Eribulin mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Cancer focused on measuring Phase I, Pediatric, Cancer, Lymphoma, Eribulin
Eligibility 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
Sites / Locations
- Jimmy Everest Center for Cancer and Blood Disorders in Children
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eribulin
Arm Description
All patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients.
Outcomes
Primary Outcome Measures
Maximum tolerated dose
The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects
Secondary Outcome Measures
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.
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
Tumor response
Subjects receiving eribulin will have scans approximately every 6 weeks to assess whether the tumors are growing, shrinking, or remaining stable.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02082626
Brief Title
Study of Eribulin in Children With Cancer to Determine Safety
Acronym
ERIBULIN
Official Title
A Phase I Study of Eribulin, a Novel Microtubule Inhibitor, in Children With Refractory or Recurrent Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Competing study opened
Study Start Date
February 1, 2014 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cancer, Solid Tumors, Lymphoma
Keywords
Phase I, Pediatric, Cancer, Lymphoma, Eribulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eribulin
Arm Type
Experimental
Arm Description
All patients will receive the experimental agent eribulin. The dose will increase with subsequent cohorts of patients.
Intervention Type
Drug
Intervention Name(s)
Eribulin mesylate
Other Intervention Name(s)
Halaven
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Description
The dose that does not cause dose limiting toxicity during the first cycle in more than 1 of 6 subjects
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pharmacokinetics of eribulin in children with cancer
Description
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
Title
Tumor expression of BRCP and ABCB1
Description
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
Title
Tumor response
Description
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rene Y McNall-Knapp, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda Linz, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jimmy Everest Center for Cancer and Blood Disorders in Children
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Eribulin in Children With Cancer to Determine Safety
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