CLINICAL TRIAL: ACTIVE IMMUNOTHERAPY AFTER RESECTION OF HEPATIC METASTASES OF CO

临床试验：CO 肝转移切除后的主动免疫治疗

• 批准号: 7719587
• 负责人: DAVID J COLE
• 金额: $ 0.16万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719587
• 关键词: Active Immunotherapy; Cells; Clinical Trials; Colon Carcinoma; Computer Retrieval of Information on Scientific Projects Database; Consent; Control Groups; Dendritic Cells; Excision; Fowlpox-CEA(D609)-MUC1(L93)-Tricom Vaccine; Funding; Grant; Granulocyte-Macrophage Colony-Stimulating Factor; Human; Immune; Immune system; Immunization; Institution; Investigational Drugs; Malignant Neoplasms; Metastatic Neoplasm to the Liver; National Cancer Institute; Operative Surgical Procedures; Pharmaceutical Preparations; Proteins; Purpose; Randomized; Research; Research Personnel; Resources; Source; Study Subject; United States Food and Drug Administration; United States National Institutes of Health; Vaccine Therapy; Virus; cancer cell; cancer recurrence; chemotherapy; rVaccinia-CEA(D609)/MUC1(L93)/TRICOM Vaccine

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. The purpose of this study is to determine if one of two immunization therapies is the most effective in keeping the cancer from recurring following surgery and chemotherapy. This study is being sponsored by a grant from the National Cancer Institute (NCI). Therion Biologics is supplying some of the investigational drugs (PANVAC-F and PANVAC-V) used in this study. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) for use in humans. The two ways to stimulate the immune system are called 1) PANVAC-V followed by PANVAC-F along with GM-CSF. This involves being injected with two different kinds of viruses that can tell the immune system to attack cancer cells that contain the protein CEA found in most colon cancers. GM-CSF is an immune stimulating molecule. 2) Dendritic cells plus PANVAC-V followed by dendritic cells plus PANVAC-F. This involves being injected with special immune stimulating cells normally found in the body called dendritic cells, mixed with the two kinds of viruses. In this study, subjects will be randomly assigned to receive either the PANVAC-V followed by PANVAC-F along with GM-CSF or dendritic cells plus PANVAC-V followed by dendritic cells plus PANVAC-F. Control subjects not receiving either treatment will have their own consent, allowing the PI to collect information on their treatments and follow-ups. This control group will serve as a comparison to those people who received vaccine therapy as a way to determine if there are any differences in cancer recurrence.

这个子项目是许多利用 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。 这项研究的目的是确定两种免疫疗法中的一种是否是最有效的，以防止癌症在手术和化疗后复发。这项研究由美国国家癌症研究所（NCI）资助。Therion Biologics提供本研究中使用的一些研究药物（PANVAC-F和PANVAC-V）。研究药物是尚未被美国食品药品监督管理局（FDA）批准用于人类的药物。 刺激免疫系统的两种方法称为1）PANVAC-V，然后是PANVAC-F沿着GM-CSF。 这涉及注射两种不同类型的病毒，可以告诉免疫系统攻击含有大多数结肠癌中发现的CEA蛋白的癌细胞。 GM-CSF是一种免疫刺激分子。 2)树突状细胞加PANVAC-V，然后是树突状细胞加PANVAC-F。 这包括注射通常在体内发现的特殊免疫刺激细胞，称为树突细胞，与两种病毒混合。在本研究中，受试者将被随机分配接受PANVAC-V，随后接受PANVAC-F沿着GM-CSF，或接受树突状细胞+PANVAC-V，随后接受树突状细胞+PANVAC-F。 未接受任何一种治疗的对照受试者将获得其本人的知情同意，允许PI收集其治疗和随访信息。 这个对照组将与接受疫苗治疗的人进行比较，以确定癌症复发是否有任何差异。