GENE THERAPY FOR BRAIN TUMORS USING ANTISENSE CDNA TRANSCRIPTION GROW

本I期研究的目的是确定与IGF-I反义RNA基因治疗相关的毒性和其他风险。 将招募12名年龄在18岁及以上、经确认组织学诊断为多形性胶质母细胞瘤的患者。 这项研究正在进行中。三种剂量水平已被提出：10，50，1亿和1亿自体，辐照和转染的多形性胶质母细胞瘤细胞。 研究设计包括3个队列，每个队列4名患者。 第一组患者将以最低剂量水平接受治疗。 当令人满意地确定没有发生研究进展的主要禁忌症时，将在以下队列中顺序增加剂量。 每例患者将在指定时间段（第1天、第4周和第12周）接受3次皮下注射。对于每一个患者，所有三次注射将以相同剂量的细胞进行。该方案根据大学医院癌症中心临床试验委员会的建议进行了修订。 修订方案于1998年4月20日获得IRB批准。 此后，本研究招募了1例患者。

The purpose of this phase I study is to identify toxicity and other risk associated with this IGF-I Antisense RNA gene therapy treatment. Twelve patients ages 18 and older with a confirmed histological diagnosis of glioblastoma multiforme will be recruited. The study is in progress. Three dose levels have been proposed: 10, 50, and 100million autologous, irradiated, and transfected glioblastoma multiforme cells. The study design includes three cohorts of 4 patients each. The first cohort of patients is to be treated at the lowest dose level. When it is satisfactorily determined that no major contraindications to progresssion of the study have occurred, the dose will be sequentially increased in the following cohorts. Each patient is to receive three subcutaneous injections at the time periods designated (Day 1, 4 weeks, and 12 weeks). For each individual patient, all three injections will be at the same dose of cells. The protocol was revised according to recommendations made by the University Hospitals Cancer Center Clinical Trials Committee. The amended protocol was approved by the IRB 4/20/98. Subsequent to that time, one patient has been recruited to this study.