ADVL0319 PHASE I STUDY OF CC-5013 (LENALIDOMIDE) IN PEDIATRIC PATIENTS

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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 new drug called CC-5013, or lenalidomide in solid tumor patients and in patients with myelodysplastic syndrome. CC-5013 works to stop cancer cells from growing by blocking certain cell processes, causing the cell to die. There have been no trials of CC-5013 in children yet. The goals of this study are to test the safety of CC-5013, to see what effects (good and bad) it has on children and children's cancer, and to find the highest dose of CC-5013 that can be given to children with solid tumors without causing severe side effects, to learn how the body handles the drug, to better understand the functions in tumor cells that differ from healthy cells and to study the anti tumor effect of CC-5013 in solid tumor and MDS patients. CC-5013 will be given to children every day for 21 days, with a period of 7 days to rest before the next course begins (each course is 28 days). Patients on this study can be given CC-5013 as long as their cancer is not getting worse, and as long as no bad side effects happen, for up to 12 courses. Children on this study will be given standard medical exams during therapy, such as physical exams, blood tests, and scans or other tests to evaluate their tumor. Patients will be the given the option to have blood samples taken for pharmacokinetics and for tests to learn what CC-5013 does to immune functions.