COG ADVL0214: A PHASE I STUDY OF SINGLE AGENT OSI-774 (TARCEVA)

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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 study has recently closed to accrual. The official notice of closure is submitted with this status report and is dated 01/20/2006. We would like to transfer this study to "COG LTF1-Long Term Follow up of Patients Previously Entered on Children's Cancer Group Clinical Trials-IRB # 97-0131-09" to maintain future follow up data submission and retrieval, as analysis is not yet completed for this study. We have no patients actively enrolled at this site. An abstract of the research is provided below for your review. This phase I study tests the safety of a new experimental drug called OSI-774, alone and in combination with temozolomide, which is an anti-tumor drug already being used to treat other types of cancer. Laboratory experiments performed with OSI-774 on cancer cells showed that OSI-774 works to slow cell growth by affecting the ability of the cell to carry out many normal functions. OSI-774 and the combination of OSI-774 and temozolomide have been tested in the adult population, and temozolomide has been used in children. OSI-774 has not been tested in children. The goals of this study are to test the safety of OSI-774, by itself and also with temozolomide in children, to see what effects (good and bad) they have on children and children's cancer, and to find the highest dose of OSI-774 that can be given to children without causing serious side effects. Other goals of this study are to learn how the body handles the drug, and to understand the effects OSI-774 has on tumor tissue. The study is designed such that the children are separated into groups of 3 or 6. The first group of children will be given OSI-774 at the starting dose and will be monitored for serious side effects. If the side effects are not too serious for the first group of children, the next group of children will be given a higher dose of OSI-774, and the next group a higher dose. This process will continue until the maximum dose is found that does not result in unacceptable side effects. The doses of OSI-774 and temozolomide given will not be increased for each individual child, but may be decreased if serious side effects are seen. Each course of therapy will last 28 days. Only the OSI-774 will be taken during the first course of therapy. OSI-774 comes in a liquid form that can be given into a vein; however, in this study the OSI-774 liquid is mixed with a sweet-tasting flavoring solution for the child to drink. During the second course of drug therapy and during each course after that, the child will continue to drink the OSI-774 liquid once each day along with temozolomide, taken as pills for the first five days of each course. The temozolomide pills can be opened up and mixed in applesauce or apple juice. An outline of the treatment course is outlined below: Course 1 Days 1-28 OSI-774 (OSI) OSI Courses 2 and higher Days 1 2 3 4 5 6-28 OSI-774 (OSI) OSI OSI OSI OSI OSI OSI Temozolomide (TEM) TEM TEM TEM TEM TEM