COMBRETASTATIN/DOXORUBICIN/CISPLATIN FOR PATIENTS WITH THYROID CANCER

康布他汀/阿霉素/顺铂用于甲状腺癌患者

• 批准号: 7378051
• 负责人: Scot C Remick
• 金额: $ 2.09万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378051
• 关键词: COMBRETASTATIN; DOXORUBICIN; CISPLATIN; PATIENTS; THYROID

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This investigator-initiated study is based on preclinical data and previous Phase I clinical experience in patients with thyroid cancer who were treated with Combretastatin A-4 Phosphate (CA4P). Results from those studies suggest that CA4P is suitable for further clinical development in the Phase II setting as part of combined modality treatment for anaplastic thyroid cancer with the potential to define a new standard of care for these patients. The objectives of the study are: 1) to determine the objective response rate of CA4P-based combined modality therapy (with concurrent radiation and consolidation treatment) given to patients with newly diagnosed regionally advanced anaplastic carcinoma of the thyroid; 2) to determine whether CA4P-based combined modality therapy alters the natural history of anaplastic thyroid cancer by virtue of doubling the median survival of these patients from 10 months to 20 months; 3) to further characterize a tolerable dose and the safety profile of CA4P when administered as part of a combined modality regimen; and 4) to determine clinical predictors of response to CA4P-based combined modality therapy by analysis of several measures including pharmacokinetics. This study plans to enroll up to 33 subjects (with up to 27 subjects at this site). The study is separated into three phases: Induction Phase, Combined Modality Phase (with dose escalation of CA4P), and Consolidation Phase. During the Induction Phase, subjects will receive initial combination chemotherapy for 1 cycle (3 weeks) (doxorubicin + cisplatin + G-CSF (granulocyte-colony stimulating factor) or neulasta). In the Combined Modality Phase, subjects will receive CA4P and radiation therapy for 4 weeks and then spend 4-6 weeks recovering. In the Consolidation Phase, CA4P will be administered for two 4-week cycles. Study monitoring will include vital signs, EKGs and pharmacokinetic sampling.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。这项研究者发起的研究基于临床前数据和之前接受康布他汀 A-4 磷酸盐 (CA4P) 治疗的甲状腺癌患者的 I 期临床经验。这些研究的结果表明，CA4P 适合在 II 期临床中进行进一步的临床开发，作为未变性甲状腺癌联合治疗的一部分，有可能为这些患者制定新的护理标准。该研究的目的是： 1) 确定对新诊断的区域晚期甲状腺未分化癌患者进行基于 CA4P 的联合治疗（同时放疗和巩固治疗）的客观缓解率； 2) 确定基于 CA4P 的联合疗法是否能改变未分化甲状腺癌的自然病程，使这些患者的中位生存期从 10 个月增加一倍至 20 个月； 3) 进一步表征 CA4P 作为联合治疗方案的一部分给药时的耐受剂量和安全性； 4) 通过分析包括药代动力学在内的多项指标来确定对基于 CA4P 的联合疗法的反应的临床预测因子。本研究计划招募最多 33 名受试者（本网站最多招募 27 名受试者）。该研究分为三个阶段：诱导阶段、联合模式阶段（CA4P 剂量递增）和巩固阶段。在诱导阶段，受试者将接受 1 个周期（3 周）的初始联合化疗（阿霉素 + 顺铂 + G-CSF（粒细胞集落刺激因子）或 neulasta）。在联合治疗阶段，受试者将接受 4 周的 CA4P 和放射治疗，然后花费 4-6 周的时间进行康复。在巩固阶段，CA4P 将进行两个为期 4 周的周期。研究监测将包括生命体征、心电图和药代动力学采样。