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首页> 外文期刊>Anticancer Research: International Journal of Cancer Research and Treatment >Phase I trial of Wilms' Tumor 1 (WT1) peptide vaccine with GM-CSF or CpG in patients with solid malignancy.
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Phase I trial of Wilms' Tumor 1 (WT1) peptide vaccine with GM-CSF or CpG in patients with solid malignancy.

机译:实体恶性肿瘤患者使用带有GM-CSF或CpG的Wilms肿瘤1(WT1)肽疫苗进行I期试验。

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摘要

The aim of this study was to investigate the safety and efficacy of combinatorial use of granulocyte-macrophage colony-stimulating factor (GM-CSF) and CpG oligodeoxynucleotides (CpG-ODN) as immunoenhancement adjuvants in Wilms' Tumor 1 (WT1) vaccine therapy for patients with solid malignancy.The patients were placed into treatment groups as follows: WT1 peptide alone, WT1 peptide with GM-CSF (100 μg) and WT1 peptide with CpG-ODN (100 μg). HLA-A *2402 or *0201/*0206-restricted, WT1 peptide emulsified with Montanide ISA51 was injected intradermally every week for eight weeks. Toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events ver. 3.0. Tumor size, which was measured by computed tomography, was determined every four weeks. The responses were analyzed according to Response Evaluation Criteria in Solid Tumors.The protocol was well tolerated; only local erythema occurred at the WT1 vaccine injection site. The disease control rate of the groups treated with WT1 peptide alone (n=10), with combinatorial use of GM-CSF (n=8) and with combinatorial use of CpG-ODN (n=10), in the initial two months was 20%, 25% and 60%, respectively.Addition of GM-CSF or CpG-ODN to the WT1 peptide vaccine for patients with solid malignancy was safe and improved the effectiveness of clinical response.
机译:这项研究的目的是调查联合使用粒细胞巨噬细胞集落刺激因子(GM-CSF)和CpG寡脱氧核苷酸(CpG-ODN)作为Wilms肿瘤1(WT1)疫苗治疗中免疫增强佐剂的安全性和有效性将患者分为以下治疗组:单独的WT1肽,带有GM-CSF的WT1肽(100μg)和带有CpG-ODN的WT1肽(100μg)。每周皮内注射用Montanide ISA51乳化的HLA-A * 2402或* 0201 / * 0206限制的WT1肽,持续八周。根据美国国家癌症研究所不良事件通用术语标准ver。评估毒性。 3.0。每四周测定一次通过计算机断层摄影术测量的肿瘤大小。根据实体瘤反应评估标准对反应进行了分析。 WT1疫苗注射部位仅发生局部红斑。在最初的两个月中,单独使用WT1肽(n = 10),联合使用GM-CSF(n = 8)和联合使用CpG-ODN(n = 10)治疗的组的疾病控制率为: WT1肽疫苗在实体恶性肿瘤患者中添加GM-CSF或CpG-ODN分别为20%,25%和60%,是安全的,并提高了临床反应的有效性。

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