TRICOM + TAXOTERE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目标： 1)用ELISPOT法测定不同剂量和给药方案对CEA特异性T细胞免疫应答的影响 2)根据最佳免疫反应和可接受的毒性来确定进一步研究的推荐剂量和时间表 3)记录发生的任何客观的抗肿瘤反应 4)以实时定量聚合酶链式反应为中间终点，确定治疗对循环CEA细胞数量的影响 医学相关性： 携带CEA的晚期转移性结肠癌或肺癌患者的治疗选择非常有限，而且现有的治疗方法尚未被证明能提高总体存活率。这是一个需要新疗法的人群。癌症免疫治疗和靶向治疗在过去几年中取得了显着进展，但单独应用可能会成功稳定疾病，但在有沉重肿瘤负担的患者中引起重大反应的潜力有限。探索免疫疗法与化疗的结合是进一步为这类患者开发新的治疗方案的合乎逻辑的下一步。 预期结果： 本试验的终点是： 1)根据标准RECIST标准测量的肿瘤反应 2)免疫反应将由ELISPOT测量 3)记录患者的经历和毒性反应，并测定毒性发生率。 4)用RT-PCR法检测循环癌细胞的数量。 预计这项试验将确定疾病反应、免疫反应和毒性的最佳组合，以推进大型第二阶段试验。

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. Objectives: 1)To determine the impact of the varying does and schedules of doctetaxel on CEA-specific T cell immune responses using the ELISPOT assay 2) To determin the recommended dose and schedule for further study as defined by the best immune response with acceptable toxicity 3) To document any objective antitumor response that occurs 4) To determine the impact of treatment on the quantity of circulating CEA cells using quantative real time PCR as an intermediate endpoint Medical Relevance: Patients with advanced metastatic CEA-bearing cancers of the colon or lung have very limited treatment options and those available have not been proven to improve overall survival. This is a population for which new therapies are needed. Cancer immunotherapy and target therapy has made significant advances in the last few years but when given alone they may succeed in stabilization of disease but have limited potential for causing major responses in patients with heavy tumor burden. Exploration of the combination of immunotherapy with chemotherapy is a logical next step to take in furthering the development of new treatment options for this group of patients. Expected Outcome: The endpoints of this trial are: 1) Tumor response measured according to standard RECIST criteria 2) Imune response will be measured by ELISPOT 3) The number of patients experiencing and toxicities will be recorded and the toxicity rate will be determined. 4) The number of circulating cancer cells will be determined by RT-PCR. It is expected that this trial will identify the best combination of terms of disease response, immune response, and toxicity to bring forward into a large Phase II trial.