A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors

Inclusion criteria

• . Hematopoietic growth factor: At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim.
• . XRT: At least 7 days since the last dose of local palliative radiation therapy. Greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation.
• . Autologous or Allogenic Stem Cell Transplant: Complete resolution of graft versus host disease and no current need for immunosuppressive medication. Greater than 3 months must have elapsed since engraftment and no longer requiring transfusion of platelets or injection of colony stimulating factors.
• . Peripheral absolute neutrophil count (ANC) ≥ 750/µL
• . Platelet count ≥ 75,000/µL (no platelet transfusion within 7 days prior to obtaining laboratory result)
• . Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age
• . SGPT (ALT) ≤ 3 x ULN
• . Serum albumin ≥ 2gm/dL Due to the risk of hepatic injury, including fatal hepatic failure, temozolomide should not be administered if total bilirubin is \>2.0 mg/dl or SGPT(ALT)\> 3 x ULN.

Exclusion criteria