A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors
M.D. Anderson Cancer Center
Summary
To find the recommended dose of eribulin that can be given in combination with irinotecan and temozolomide to treat relapsed and/or refractory solid tumors.
Description
Primary Objectives: * To determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of eribulin in combination with fixed doses of irinotecan and temozolomide. * To determine the safety and tolerance of Eribulin when given in conjunction with Irinotecan and Temozolamide (IT) in children with refractory and relapsed (R/R) solid tumors. Secondary Objectives: --To observe and record disease response (anti-tumor activity). Although the clinical benefit of Eribulin when given together with Irinotecan and Temozolamide has not yet been established, the intent of offering this trea…
Eligibility
- Age range
- 1–25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age: Patients must be \> 1 year of age and ≤ 25 years of age at time of initiation of protocol therapy. * Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory solid tumor. * Disease Status: Patients must have evaluable disease. * Patients may have CNS metastases at study entry, if they are previously treated or stable (defined by not requiring initation or increased steroids for 7 days). * Performance Level: Karnofsky ≥ 50% for patients \>16 years old, and Lansky ≥ 50 for patients 1-16 years old. (Appendix I) * Prior Therapy: Pat…
Interventions
- DrugEribulin
Given by vein (IV)
- DrugIrinotecan
Given by vein (IV)
- DrugTemozolomide
Given by PO
Location
- M D Anderson Cancer CenterHouston, Texas