A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed 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 treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief. Outcomes for disease response include Best Overall Response (BOR), Duration of Response (DOR), and Progression-Free Survival (PFS).