A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors
Trial Parameters
Brief 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.
Eligibility Criteria
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: Patients may have received prior therapy including single-agent irinotecan or temozolomide. Patients may not have previously been treated with combination therapy of irinotecan and temozolomide. * Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. 1. Hematopoietic growth factor: At least 7 days must have