COG ADVL0419: VALPROIC ACID IN CHILDREN WITH RECURRENT/PROGRESSIVE SOLID TUMORS

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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. Valproic acid has been approved by the FDA, but has not been approved specifically for treating children with solid tumors. It is not known if valproic acid will kill tumor cells in children, or what the lowest level of drug needed in the body is to kill tumor cells, therefore, the major goal of the study is to learn if children with cancer can safely take valproic acid at levels higher than those commonly given to epilepsy patients. Other goals of this study are to learn what kinds of side effects happen in children with cancer when they take valproic acid at a higher dose than is commonly given to epilepsy patients, to learn if children with solid tumors handle valproic acid any differently than children with epilepsy (called a pharmacokinetic study, or PK study), and to study whether valproic acid causes histone acetylations (a biological change in normal or tumor cells which we believe is responsible for killing tumor cells). Each course of therapy lasts 28 days (or 4 weeks), except for the first course, which may last much longer than 28 days (from 5 to 10 weeks). After the first course, valproic acid will be given at the dose found to maintain blood valproic acid at the target level. A maximum of 12 courses of therapy may be administered.