RATIONALE: MLN8237 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of MLN8237 and to see how well it works in treating young patients with relapsed or refractory solid tumors
Name: MLN8237
Description: DLT will be defined as possibly, probably or definitely attributable to MLN8237. The DLT observation period for the purposes of dose-escalation will be the first cycle of therapy
Measure: Adverse events as assessed by (CTCAE) version 4.0 Time: Every 21 days (each cycle) of protocol therapy for up to 35 cycles [up to 105 weeks]Description: single-dose AUC, trough estimation, t½ of accumulation
Measure: PK Profile: MLN8237 concentrations in plasma samples Time: 30 min after the first dose, and at 1,2, 3, 4, 6-8, 24 hours, Day 4 and 7 in Cycle 1Allocation: Non-Randomized
Parallel Assignment
There are 2 SNPs
To assess two common polymorphic variants in the Aurora A kinase gene (Phe31Ile and Val57Ile) thought to potentially influence tumorigenesis. --- Phe31Ile ---
To assess two common polymorphic variants in the Aurora A kinase gene (Phe31Ile and Val57Ile) thought to potentially influence tumorigenesis. --- Phe31Ile --- --- Val57Ile ---