Open Label Phase II Clinical Trial of Myoma Immunotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in tumor size compared to baseline
研究概览
简要总结
Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.
详细描述
Myoma or uterine fibroids are one of the most common gynecological diseases, which occurs in at least one third of women older than 35 years, and after 40 - in every second. We will test a new tablet preparation, V3-Myoma, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with uterine myoma. When administered orally, V3-Myoma should cause a specific anti-tumor immune response and an anti-inflammatory effect. Such an effect is due to the phenomenon known in immunology, called oral tolerance, leading to a reduction in tumor mass and a decrease in inflammation. An important advantage of our approach is the absence of any negative side effects. In the next three month, we will conduct Phase II open label clinical study of this intervention in 30 women with confirmed diagnosis of myoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosed myoma with single or multiple tumors presence of typical clinical symptoms associated with myoma -
排除标准
- •other gynecological diseases not related to myoma hysterectomy
研究组 & 干预措施
Single arm receiving V3-Myoma
A single oral pill of V3-Myoma therapeutic vaccine containing pooled antigens circulating in peripheral blood and within myoma tissues
干预措施: V3-Myoma (Biological)
结局指标
主要结局
Change in tumor size compared to baseline
时间窗: Once monthly for three months
This parameter will be evaluated by pelvic examination and transvaginal ultrasonography
次要结局
- Changes in frequent urination or difficulty in emptying the bladder or constipation(3 months)
- Changes in level of pain associated with myoma, low back and legs, pelvic pressure and pain, if any(3 months)
- Changes in bleeding pattern at and between menstruations(During and between periods for three months)