Open Label Immunotherapy of Myoma

Leiomyoma Clinical Trial

— V3-myoma  

Official title:

Open Label Phase II Clinical Trial of Myoma Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03550703
• Other study ID #: Myoma01
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2018
• Source: Immunitor LLC
• Contact: Galyna Kutsyna, MD, MD/PhD
• Phone: +97695130306
• Email: kutsynagalyna[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

diagnosed myoma with single or multiple tumors presence of typical clinical symptoms associated with myoma -

Exclusion Criteria:

other gynecological diseases not related to myoma hysterectomy

Related Conditions & MeSH terms

• Fibroid Uterus
• Fibroma
• Leiomyoma
• Myoma
• Myoma;Uterus

Intervention

Biological:
• V3-Myoma
Once daily oral pill of V3-Myoma

Locations

Country	Name	City	State
Mongolia	Immunitor LLC	Ulaanbaatar

Sponsors (1)

Lead Sponsor	Collaborator
Immunitor LLC

Country where clinical trial is conducted

Mongolia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tumor size compared to baseline	This parameter will be evaluated by pelvic examination and transvaginal ultrasonography	Once monthly for three months
Secondary	Changes in bleeding pattern at and between menstruations	Self-evaluated by patient	During and between periods for three months
Secondary	Changes in level of pain associated with myoma, low back and legs, pelvic pressure and pain, if any	Self evaluated by patient	3 months
Secondary	Changes in frequent urination or difficulty in emptying the bladder or constipation	Self evaluated by patient	3 months

External Links

•   review on oral vaccines