PHASE I STUDY OF HIGH DOSE INTERMITTENT CALCITRIOL IN ADVANCED MALIGNANCIES

高剂量间歇性骨化三醇治疗晚期恶性肿瘤的 I 期研究

• 批准号: 6116995
• 负责人: WILLIAM D HENNER
• 金额: $ 3.13万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 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/6116995
• 关键词: 1,25 dihydroxycholecalciferol; clinical research; clinical trial phase I; dosage; human subject; human therapy evaluation; neoplasm /cancer; nutrition related tag; vitamin therapy

Antiproliferative effects of 1,25-dihydroxyvitamin D and its analogues have been demonstrated in tissue culture and animal models of many different human cancers. Intermittent exposure to 1,25-dihydroxyvitamin D suppresses neoplastic cell growth in vitro and maybe sufficient to achieve antiproliferative effects in vivo. Toxicity of Vitamin D in humans, principally hypercalcemia, increases with duration of exposure to vitamin D. The hypothesis of they study is that intermittent dosing may produce antiproliferative levels of 1,25-disydroxyvitamin D while minimizing toxicity. Such intermittent dosing has not been studied and maximally tolerated doses of 1,25-dihydroxyvitamin D given intermittently have not been defined. We seek to define the maximally tolerated dose and optimal treatment schedule of Calcitriol delivered intermittently.

1，25-二羟维生素D及其类似物的抗增殖作用 已经在许多组织培养和动物模型中得到证实， 不同的人类癌症间歇性暴露于1，25-二羟维生素D 在体外抑制肿瘤细胞生长， 体内抗增殖作用。 维生素D对人体的毒性， 主要是高钙血症，随着暴露于维生素 D. 他们研究的假设是，间歇给药可能会产生 抗增殖水平的1，25-二羟基维生素D，同时最小化 毒性 这种间歇给药尚未研究， 间歇给予耐受剂量的1，25-二羟维生素D 被定义。 我们试图确定最大耐受剂量和最佳剂量。 间歇性给予骨化三醇的治疗方案。