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。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这项研究者发起的研究基于临床前数据和先前的I期临床经验，该甲状腺癌患者接受了Combretastatin A-4磷酸盐（CA4P）治疗。这些研究的结果表明，CA4P适合在II期设置中进一步的临床发展，这是对甲状腺塑性甲状腺癌的合并方式治疗的一部分，有可能为这些患者定义新的护理标准。该研究的目的是：1）确定对甲状腺新诊断为新诊断的区域晚期纳普癌的患者的基于CA4P的组合式疗法的客观反应率（具有同时放射和巩固治疗）； 2）确定基于CA4P的合并方式疗法是否通过使这些患者的中位生存率从10个月到20个月的中位数增加一倍，从而改变了甲状腺癌的自然史； 3）进一步表征可容忍的剂量和作为组合方式方案的一部分时CA4P的安全性； 4）通过分析包括药代动力学在内的几种措施，确定对基于CA4P的组合局部疗法的反应的临床预测指标。这项研究计划最多注册33名受试者（该站点最多有27名受试者）。该研究分为三个阶段：诱导阶段，联合形态阶段（CA4P的剂量升级）和巩固阶段。在诱导阶段，受试者将接受1个周期的初始组合化疗（阿霉素 +顺铂 + g-csf（粒细胞 - 粘合剂刺激因子）或neulasta）。在联合形态阶段，受试者将接受CA4P和放射治疗4周，然后花4-6周恢复。在合并阶段，将对两个4周的周期进行CA4P。研究监测将包括生命体征，EKG和药代动力学抽样。