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: 6219285
• 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: 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/6219285
• 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）评估第1 - 3天皮下给予的骨化三醇与第3天卡铂（ABC = 6）组合的毒性并确定其最大耐受剂量（MTD）。 2）当以比MTD小一个剂量水平的剂量与皮下骨化三醇一起在第1 - 3天给予时，评估第3天卡铂的毒性并确定其最大耐受剂量（MTD）。 3）测定骨化三醇给药对卡铂AUC的影响。 4）评估卡铂的ABC与卡铂+骨化三醇给药后观察到的骨髓抑制之间的关系。 5）评价卡铂+骨化三醇治疗恶性胶质瘤的安全性和有效性。 此外，这将使我们能够收集有关药物相互作用的重要信息。