COG ADVL0413: A PHASE I STUDY OF THE RAF KINASE AND RECEPTOR TYROSINE KINASE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This phase I study tests the safety of a drug called sorafenib (BAY43-9006) in children with refractory solid tumors or refractory leukemia. Sorafenib works by blocking proteins which are thought to be important for signaling tumor growth. Sorafenib recently received FDA approval for treatment of advanced kidney cancer which occurs mostly in adults. The goals of this study are to find the highest safe dose of Sorafenib that can be given to children with solid tumors without causing severe side effects, to find out if the highest safe dose of Sorafenib in children with solid tumors is also safe for children with leukemia, and to learn what kind of side effects Sorafenib can cause. Other goals of this study include learning how the body handles the drug, learning what effects Sorafenib has on blood cells and tumor cells, and learning more about whether Sorafenib may be a beneficial treatment for pediatric tumors. The patients will be given Sorafenib twice a day. Up to 24-28 day courses of treatment may be given. Sorafenib tablets must be swallowed whole with clear liquids. In addition to these tests, patients will be the given the option to have blood samples taken during the first course of therapy for pharmacokinetics and correlative studies. Optional studies also include DEMRIs. Once the maximum dose is found in patients with solid tumors, a group of children with refractory leukemia will be given Sorafenib at this dose.