Open Label Immunotherapy of Myoma (V3-myoma)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03550703
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : July 6, 2018
Information provided by (Responsible Party):
Immunitor LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Myoma;Uterus Fibroid Uterus Leiomyoma Fibroma Biological: V3-Myoma Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open label, single arm study
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: Open Label Phase II Clinical Trial of Myoma Immunotherapy
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: 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
Biological: V3-Myoma
Once daily oral pill of V3-Myoma

Primary Outcome Measures :
  1. Change in tumor size compared to baseline [ Time Frame: Once monthly for three months ]
    This parameter will be evaluated by pelvic examination and transvaginal ultrasonography

Secondary Outcome Measures :
  1. Changes in bleeding pattern at and between menstruations [ Time Frame: During and between periods for three months ]
    Self-evaluated by patient

  2. Changes in level of pain associated with myoma, low back and legs, pelvic pressure and pain, if any [ Time Frame: 3 months ]
    Self evaluated by patient

  3. Changes in frequent urination or difficulty in emptying the bladder or constipation [ Time Frame: 3 months ]
    Self evaluated by patient

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Myoma is a female health problem
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03550703

Contact: Galyna Kutsyna, MD, MD/PhD +97695130306
Contact: Marina Tarakanovskaya, MD +97695130306

Immunitor LLC Recruiting
Ulaanbaatar, Mongolia
Contact: Aldar Bourinbaiar, MD    97695130306   
Contact: Marina Tarakanovskaya, MD   
Principal Investigator: Galyna Kutsyna, MD         
Sponsors and Collaborators
Immunitor LLC
Study Chair: Aldar Bourinbaiar, PhD, MD/PhD Immunitor LLC

Additional Information:
Responsible Party: Immunitor LLC Identifier: NCT03550703     History of Changes
Other Study ID Numbers: Myoma01
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Upon study completion the data will be available in peer-reviewed publication

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Neoplasms, Fibrous Tissue