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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。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 研究中心，而研究中心不一定是研究者所在的机构。 目的： 1）使用ELISPOT测定确定不同剂量和时间表的多西他赛对CEA特异性T细胞免疫应答的影响 2)根据毒性可接受的最佳免疫应答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抗肿瘤反应 4)确定治疗对循环量的影响 使用定量真实的时间PCR作为中间终点的CEA细胞 医学相关性： 晚期转移性CEA结肠癌或肺癌患者的治疗选择非常有限，并且现有的治疗方案尚未被证明可以改善总生存期。 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，但单独使用时，它们可能成功稳定疾病，但在肿瘤负荷重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组患者开发新治疗方案的合理下一步。 预期结果： 本试验的终点是： 1)根据标准RECIST标准测量肿瘤缓解 2)将通过ELISPOT测量免疫应答 3)将记录发生毒性的患者数量，并确定毒性发生率。 4)将通过RT-PCR测定循环癌细胞的数量。 预计该试验将确定疾病反应、免疫反应和毒性的最佳组合，以进入大型II期试验。