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资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。本研究基于临床前数据和既往接受Combretastatin A-4 Phosphate（CA 4P）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，CA 4P适合在II期环境中进一步临床开发，作为甲状腺未分化癌综合治疗的一部分，有可能为这些患者定义新的护理标准。本研究的目的是：1）确定以CA 4P为基础的综合治疗的客观缓解率（同时进行放射和巩固治疗）给予新诊断的区域晚期甲状腺未分化癌患者; 2）确定CA 4P是否-基于联合疗法的甲状腺癌治疗改变了甲状腺未分化癌的自然病程，使这些患者的中位生存率从10个月至20个月; 3）进一步表征当作为联合模式方案的一部分施用时CA 4P的耐受剂量和安全性特征;和4）通过分析包括药代动力学在内的几种测量来确定对基于CA 4P的联合模式疗法的响应的临床预测因子。本研究计划入组最多33例受试者（该研究中心最多27例受试者）。研究分为三个阶段：诱导期、联合治疗期（CA 4P剂量递增）和巩固期。在诱导期，受试者将接受1个周期（3周）的初始联合化疗（多柔比星+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CA 4P和放射治疗，然后花4-6周时间恢复。在巩固阶段，将给予两个4周周期的CA 4P。研究监测将包括生命体征、心电图和药代动力学采样。