CHP 601--TALL 104 CELLS IN CHILDREN WITH ADVANCED RECURRENT REFRACTORY CANCER

CHP 601——患有晚期复发难治性癌症的儿童中的 TALL 104 细胞

• 批准号: 6278104
• 负责人: BEVERLY LANGE
• 金额: $ 2.4万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6278104
• 关键词: blood /lymphatic neoplasm; cell line; child (0-11); clinical research; clinical trials; cytotoxic T lymphocyte; drug administration rate /duration; human subject; human therapy evaluation; neoplasm /cancer classification /staging; neoplasm /cancer immunotherapy; neoplasm /cancer relapse /recurrence; outcomes research; tumor infiltrating lymphocyte

Seven patients have entered this trial. All seven have had extensive therapy and are very immunosuppressed. When no side effects were noted in the first 3 patients, the protocol was modified as follows: 1) allow 1 dose escalation per patient; 2) shorten interval between doses from 28 days to 14 days for first 8 weeks; 3) administer the first 48 hours in hospital, and if no side effects occur continue in the outpatient department; 4) eligibility expanded to include patients whose malignancy was diagnosed before age 21. Four patients completed therapy and all had tumor progression. Three are undergoing treatment now. Significant changes in NK activity were noted in some patients. Remarkably, in contrast to canine patients in a comparable trial, no human has made antibody to TALL-104.

已有7名患者参加了这项试验。所有七个人都有广泛的 治疗和免疫抑制非常严重。在没有发现副作用的情况下 前3名患者，方案修改如下： 1)允许每个患者增加1剂； 2)将前8天的服药间隔从28天缩短到14天 周； 3)住院前48小时服药，如无副作用 继续留在门诊部； 4)资格扩大到包括被诊断为恶性肿瘤的患者 在21岁之前。 4名患者完成了治疗，所有患者都有肿瘤进展。三个是 目前正在接受治疗。自然杀伤细胞活性的显著变化在 一些病人。值得注意的是，与犬类患者相比， 试验中，还没有人产生针对Tall-104的抗体。