FILGRASTIM ALONE OR IN COMBINATION W/ R METHUSCF IN BREAST CANCER

单独使用 FILGRASTIM 或与 METHUSCF 联用治疗乳腺癌

• 批准号: 6263870
• 负责人: Thomas C. Shea
• 金额: $ 0.02万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263870
• 关键词: CD34 molecule; breast neoplasms; clinical research; clinical trial phase I; colony stimulating factor; combination chemotherapy; female; hematopoietic growth factor; hematopoietic stem cells; human subject; human therapy evaluation; neoplasm /cancer chemotherapy

The purpose of this study is to improve mobilization of CD34+ cells with r-metHuSCF in combination with high-dose Filgrastim as compared to high-dose Filgrastim alone. 1. To compare the total 3 day yield of hematopoietic progenitor cells (CD34+ cells) collected on days 5, 6 and 7, using either 20 ug/kg/day r-metHuSCF in combination with 30 ug/kg/day of Filgrastim or 30 ug/kg/day Fugrastim alone 2. To compare the daily yield of CD34+ cells/kg collected 3. To compare the proportion of patients reaching clinically relevant PBPC yields (eg, 1 x 10^6 and 5 x 10^6 CD34+ cells/kg) 4. To assess the safety of r-metHuSCF in combination with high-dose Filgrastim

本研究的目的是与单独使用大剂量非格昔汀相比，r-metHuSCF联合大剂量非格昔汀改善CD34+细胞的动员。1. 比较20 ug/kg/day r-metHuSCF与30 ug/kg/day非格拉西汀或30 ug/kg/day单独使用第5、6和7天收集的造血祖细胞（CD34+细胞）的总3天产量2。比较收集CD34+细胞/kg的日产量。比较达到临床相关PBPC产量（例如，1 × 10^6和5 × 10^6 CD34+细胞/kg）的患者比例。评价r-metHuSCF与大剂量非格拉西汀联用的安全性