TRICOM + TAXOTERE

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。目的：1)使用ELISPOT测定多西他赛不同剂量和时间表对CEA特异性T细胞免疫反应的影响2)确定进一步研究的推荐剂量和时间表，以确定具有可接受毒性的最佳免疫反应3)记录发生的任何客观抗肿瘤反应4)使用定量实时PCR作为中间终点确定治疗对循环CEA细胞数量的影响晚期转移性结肠癌或肺癌患者的治疗选择非常有限，而且这些可用的治疗方法尚未被证明能提高总生存率。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重大进展，但如果单独使用，它们可能会成功地稳定疾病，但在肿瘤负担重的患者中引起重大反应的潜力有限。探索免疫治疗与化疗的结合是进一步为这组患者开发新的治疗方案的一个合乎逻辑的下一步。预期结果：本试验的终点是：1)根据标准RECIST标准测量肿瘤反应2)通过ELISPOT测量免疫反应3)记录患者人数和毒性，并确定毒性率。4)通过RT-PCR检测循环癌细胞的数量。预计该试验将确定疾病反应、免疫反应和毒性方面的最佳组合，并将其带入大规模的II期试验。

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.