PHASE I TRIAL OF SUBCUTANEOUS CALCITRIOL AND CARBOPLATIN IN ADVANCED SOLID TUMOR

皮下骨化三醇和卡铂治疗晚期实体瘤的 I 期试验

• 批准号: 6304709
• 负责人: DAVID TRUMP
• 金额: $ 0.3万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304709
• 关键词: 1,25 dihydroxycholecalciferol; carboplatin; clinical research; clinical trial phase I; combination cancer therapy; dosage; drug administration routes; drug adverse effect; drug interactions; human subject; human therapy evaluation; metastasis; neoplasm /cancer chemotherapy; neoplasm /cancer classification /staging; nutrition related tag; vitamin therapy

The specific aims of this protocol are: 1)to assess the toxicities of and determine the maximum tolerated dose (MTD) of subcutaneous calcitriol given Day 1 - 3 in combination with carboplatin (ABC = 6) Day 3. 2)to assess the toxicities of and determine the maximum tolerated dose (MTD) of carboplatin Day 3 when given with subcutaneous calcitriol Day 1 - 3 at a dose one dosage level less than the MTD. 3)to determine the effect of administration of calcitriol on the AUC of carboplatin. 4)to assess the relationship between the ABC of carboplatin and the myelosuppression seen following the administration of carboplatin + calcitriol. 5)to evaluate the safety and efficacy of carboplatin + calcitriol in patients with malignant glioma. Additionally, this will allow us to gather important information regarding drug interactions.

该方案的具体目的是：1）评估给定给第1-3天皮下钙化钙的毒性并确定最大耐受剂量（MTD）与卡泊蛋白（ABC = 6）的结合（ABC = 6）第3。2。2。一个剂量水平低于MTD。 3）确定钙化三醇对卡铂AUC的影响。 4）评估卡铂 +骨化三醇后观察到的卡铂的ABC与骨髓抑制之间的关系。 5）评估卡泊蛋白 +钙三醇对恶性神经胶质瘤患者的安全性和功效。 此外，这将使我们能够收集有关药物相互作用的重要信息。