VACCINIA-CEA(6D)TRICOM & FOWLPOX-CEA(6D)-TAXOTERE W/GM-CSF & DOCETAXEL

牛痘-CEA(6D)TRICOM

• 批准号: 7608454
• 负责人: JOHN L. MARSHALL
• 金额: $ 10.51万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608454
• 关键词: Antitumor Response; Biological Assay; Cells; Colon Carcinoma; Computer Retrieval of Information on Scientific Projects Database; Development; Disease; Dose; End Point; Fowlpox; Funding; Grant; Immune response; Immunotherapy; Institution; Lung; Measures; Medical; Numbers; Outcome; Patients; Phase II Clinical Trials; Polymerase Chain Reaction; Population; Rate; Research; Research Personnel; Resources; Reverse Transcriptase Polymerase Chain Reaction; Schedule; Source; Standards of Weights and Measures; T-Lymphocyte; Time; Toxic effect; Tumor Burden; United States National Institutes of Health; Vaccinia; cancer immunotherapy; chemotherapy; circulating cancer cell; docetaxel; enzyme linked immunospot assay; experience; improved; response; tumor

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。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。列出的机构是 对于中心，这不一定是调查员的机构。 目标： 1）使用ELISPOT测定 2）确定最佳免疫反应定义的建议的剂量和时间表，以可接受的毒性定义 3）记录发生的任何客观抗肿瘤反应 4）使用定量实时PCR确定治疗对循环CEA细胞数量的影响 医学相关性： 结肠或肺部晚期转移性CEA癌症患者的治疗选择非常有限，尚未证明可用的患者可以改善总体生存率。 这是需要新疗法的人群。 在过去的几年中，癌症免疫疗法和靶向疗法取得了重大进展，但是单独给予疾病的疾病可能会成功，但在肿瘤负担重的患者中产生重大反应的潜力有限。 探索免疫疗法与化学疗法的组合是促进这组患者开发新治疗选择的合乎逻辑的下一步。 预期结果： 该试验的终点是： 1）根据标准恢复标准测量的肿瘤反应 2）Imune响应将通过ELISPOT测量 3）将记录经历和毒性的患者数量，并确定毒性率。 4）循环癌细胞的数量将通过RT-PCR确定。 预计该试验将确定疾病反应，免疫反应和毒性的最佳组合，以提出大型II期试验。