UPCC 5196:PHASE I TRIAL W/ TALL 104 CELLS FOR THERAPY OF METASTATIC BREAST CANCER

UPCC 5196：使用 TALL 104 细胞治疗转移性乳腺癌的 I 期试验

• 批准号: 6263598
• 负责人: DAVID L PORTER
• 金额: $ 2.51万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 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/6263598
• 关键词: breast neoplasms; cell transplantation; clinical research; clinical trial phase I; female; human subject; human therapy evaluation; metastasis; neoplasm /cancer therapy; tumor necrosis factor alpha

The purpose of this study is to evaluate the effect of TALL-104 cells in patients with metastatic breast cancer, and to study the side effects and toxic dose levels of these cells. In order to do this, varying doses of TALL- 104 cells will be given to volunteers with metastatic breast cancer. The first women involved in this trial will be given a low dose of TALL-104 cells. If no significant side effects occur, the next group of volunteers will receive a higher dose, and this "dose escalation" will continue until either 1) a dose is identified that causes too many side effects or 2) the dose has been increased 4 tims to the highest dose to be used in this study.

本研究的目的是评价TALL-104细胞在转移性乳腺癌患者中的作用，并研究这些细胞的副作用和毒性剂量水平。为了做到这一点，不同剂量的TALL-104细胞将被给予患有转移性乳腺癌的志愿者。参与这项试验的第一批女性将被给予低剂量的TALL-104细胞。如果没有发生明显的副作用，下一组志愿者将接受更高的剂量，这种“剂量递增”将继续下去，直到1)确定一个剂量会导致太多的副作用，或者2)剂量已经增加了4倍，达到本研究中使用的最高剂量。