Open Label Immunotherapy of Myoma (V3-myoma)
Primary Purpose
Myoma;Uterus, Fibroid Uterus, Leiomyoma
Status
Unknown status
Phase
Phase 2
Locations
Mongolia
Study Type
Interventional
Intervention
V3-Myoma
Sponsored by
About this trial
This is an interventional treatment trial for Myoma;Uterus
Eligibility Criteria
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
-
Sites / Locations
- Immunitor LLCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm receiving V3-Myoma
Arm Description
A single oral pill of V3-Myoma therapeutic vaccine containing pooled antigens circulating in peripheral blood and within myoma tissues
Outcomes
Primary Outcome Measures
Change in tumor size compared to baseline
This parameter will be evaluated by pelvic examination and transvaginal ultrasonography
Secondary Outcome Measures
Changes in bleeding pattern at and between menstruations
Self-evaluated by patient
Changes in level of pain associated with myoma, low back and legs, pelvic pressure and pain, if any
Self evaluated by patient
Changes in frequent urination or difficulty in emptying the bladder or constipation
Self evaluated by patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03550703
Brief Title
Open Label Immunotherapy of Myoma
Acronym
V3-myoma
Official Title
Open Label Phase II Clinical Trial of Myoma Immunotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunitor LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma;Uterus, Fibroid Uterus, Leiomyoma, Fibroma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
open label, single arm study
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm receiving V3-Myoma
Arm Type
Experimental
Arm Description
A single oral pill of V3-Myoma therapeutic vaccine containing pooled antigens circulating in peripheral blood and within myoma tissues
Intervention Type
Biological
Intervention Name(s)
V3-Myoma
Intervention Description
Once daily oral pill of V3-Myoma
Primary Outcome Measure Information:
Title
Change in tumor size compared to baseline
Description
This parameter will be evaluated by pelvic examination and transvaginal ultrasonography
Time Frame
Once monthly for three months
Secondary Outcome Measure Information:
Title
Changes in bleeding pattern at and between menstruations
Description
Self-evaluated by patient
Time Frame
During and between periods for three months
Title
Changes in level of pain associated with myoma, low back and legs, pelvic pressure and pain, if any
Description
Self evaluated by patient
Time Frame
3 months
Title
Changes in frequent urination or difficulty in emptying the bladder or constipation
Description
Self evaluated by patient
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Myoma is a female health problem
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Galyna Kutsyna, MD, MD/PhD
Phone
+97695130306
Email
kutsynagalyna@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Tarakanovskaya, MD
Phone
+97695130306
Email
info@immunitor.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldar Bourinbaiar, PhD, MD/PhD
Organizational Affiliation
Immunitor LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Immunitor LLC
City
Ulaanbaatar
Country
Mongolia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldar Bourinbaiar, MD
Phone
97695130306
Email
aldar@immunitor.com
First Name & Middle Initial & Last Name & Degree
Marina Tarakanovskaya, MD
Email
marinatarakanovskaya@yahoo.com
First Name & Middle Initial & Last Name & Degree
Galyna Kutsyna, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Upon study completion the data will be available in peer-reviewed publication
Learn more about this trial
Open Label Immunotherapy of Myoma
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