A Phase II Study of MLN8237 (IND# 102984), a Selective Aurora A Kinase Inhibitor in Children with Recurrent/Refractory Solid Tumors and Leukemias
MLN8237 inhibits a protein that is overexpressed in many types of tumors- aurora A kinase. Aurora A kinase is necessary for the cell growth and division of cancer cells. The purpose of this study is to determine the response rate to MLN8237 in children with relapsed or refractory solid tumors and leukemias, as well as to learn more about how MLN8237 is metabolized in children.
Age greater than 12 months and less than / equal to 21 years. Must have either: a) Neuroblastoma- measurable b) Neuroblastoma- MIBG evaluable c) Rhabdomyosarcoma d) Osteosarcoma e) Ewing sarcoma/Peripheral PNET f) Non-RMS soft tissue sarcoma g) Hepatoblastoma h) Malignant germ cell tumor i) Wilms tumor j) Acute lymphoblastic leukemia k) Acute myelogenous leukemia. Must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment. Adequate organ function. Leukemia patients with CNS disease are not eligible.
MLN8237 is an oral medication given once daily for days 1-7, repeated every 21 days. Treatment may continue for 24 months as long as there is no disease progression or drug-related toxicity.
06/17/2013 04:02 AM