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

COG ADVL0214：单药 OSI-774 (TARCEVA) 的 I 期研究

• 批准号: 7379432
• 负责人: JULIE R PARK
• 金额: $ 0.25万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379432
• 关键词: COG; ADVL0214; PHASE; STUDY; SINGLE

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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究最近已接近应计。关闭的正式通知随本状态报告一起提交，日期为2006年1月20日。我们希望将这项研究转移到“COG LTF1--以前参加儿童癌症小组临床试验的患者的长期随访-IRB#97-0131-09”，以保持未来的随访数据提交和检索，因为本研究的分析尚未完成。我们在这个网站上没有积极登记的患者。下面是这项研究的摘要，供您参考。这一阶段的研究测试了一种名为OSI-774的新实验药物的安全性，该药物单独和与替莫唑胺联合使用，替莫唑胺是一种已经被用于治疗其他类型癌症的抗肿瘤药物。使用OSI-774对癌细胞进行的实验室实验表明，OSI-774通过影响细胞执行许多正常功能的能力来减缓细胞生长。OSI-774和OSI-774与替莫唑胺的组合已经在成人人群中进行了测试，替莫唑胺已经在儿童中使用。OSI-774尚未在儿童身上进行测试。这项研究的目的是测试OSI-774本身以及与替莫唑胺在儿童中的安全性，看看它们对儿童和儿童癌症有什么影响(好的和坏的)，并找到可以给儿童服用而不会引起严重副作用的最高剂量的OSI-774。这项研究的其他目标是了解身体如何处理药物，并了解OSI-774对肿瘤组织的影响。这项研究的设计是将儿童分为3组或6组。第一组儿童将在开始剂量时服用OSI-774，并将监测严重副作用。如果第一组儿童的副作用不太严重，下一组儿童将被给予更高剂量的OSI-774，下一组儿童将被给予更高剂量。这一过程将继续下去，直到找到不会导致不可接受的副作用的最大剂量。OSI-774和替莫唑胺的剂量不会针对每个儿童增加，但如果出现严重的副作用，可能会减少。每个疗程将持续28天。在第一个疗程中，只有OSI-774将被服用。OSI-774呈液体形式，可注入静脉；然而，在这项研究中，OSI-774液体与甜味调味液混合，供儿童饮用。在第二个疗程和之后的每个疗程中，儿童将继续每天喝一次OSI-774液体，同时服用替莫唑胺，作为每个疗程的前五天的药片。替莫唑胺药丸可以打开，并与苹果酱或苹果汁混合。疗程概述如下：疗程1天1-28天OSI-774(OSI)OSI疗程2及以上1天2 3 4 5 6-28 OSI-774(OSI)OSI替莫唑胺(TEMTM)