In Vitro Functional Modulation of Monocyte-derived Dendritic Cells of Patients With Cancer by Peptides
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Cytokines production by the dendritic cells (DCs) after stimulation with the peptides.
研究概览
简要总结
The purpose of this study is to evaluate in vitro the potential of peptides, to modify, phenotypically and functionally, the monocyte-derived dendritic cells of patients with metastatic cancer.
详细描述
The DCs will be generated in vitro from peripheral blood mononuclear cells (PBMCs) which will be obtained from 30 ml of peripheral blood collected from each patient with metastatic cancer by venipuncture in heparin tubes.
The cellular viability, the expression of maturation biomarkers and the presence of several cytokines will be evaluated by flow cytometric assays after the culture period of DCs exposed to the peptides.
An interim analysis is programmed with the first 10 patients. If an effect is demonstrated the study will include an additional number of subjects sufficient to ensure adequate comparison with other commercially available peptides.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of the Informed Consent Form before the performing of any procedures related to the study;
- •Age ≥18 years;
- •Histologically confirmed metastatic malignant neoplasia;
- •Results of laboratorial exams in the first 6 weeks before the blood sample collection within the following values:
- •White blood cells ≥ 3.000/μL;
- •Platelet count ≥ 100,000/mm³;
- •Hemoglobin > 10g/dL;
- •Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and alkaline phosphatase < 2.5 x upper limit of normal (ULN);
- •Serum creatinine < 1.5 x upper limit of normal (ULN);
- •Karnofsky performance status ≥ 70%.
排除标准
- •Presence of autoimmune disorders or conditions that require systemic treatment with immunosuppressant medications or systemic corticosteroids;
- •Received any systemic chemotherapy or radiotherapy within 15 days prior to the blood sample collection;
- •Received any immunotherapy within 4 weeks prior to the blood sample collection;
- •Known history of positive serology for HIV (human immunodeficiency virus).
结局指标
主要结局
Cytokines production by the dendritic cells (DCs) after stimulation with the peptides.
时间窗: At the seventh day of the cells culture period
Viability of the dendritic cells (DCs) after stimulation with the peptides.
时间窗: At the seventh day of the cells culture period
Expression of cellular markers in the dendritic cells (DCs) after stimulation with the peptides.
时间窗: At the seventh day of the cells culture period
次要结局
未报告次要终点