Open Label Immunotherapy of Myoma

NCT03550703 | Unknown Phase 2

• 1 other identifier: Myoma01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Myoma;Uterus; Fibroid Uterus; Leiomyoma; Fibroma

Outcome Measures

Primary Outcomes (1)

• Change in tumor size compared to baseline

  This parameter will be evaluated by pelvic examination and transvaginal ultrasonography

  Once monthly for three months

Secondary Outcomes (3)

• Changes in bleeding pattern at and between menstruations

  During and between periods for three months

• Changes in level of pain associated with myoma, low back and legs, pelvic pressure and pain, if any

  3 months

• Changes in frequent urination or difficulty in emptying the bladder or constipation

  3 months

Study Arms (1)

Single arm receiving V3-Myoma

EXPERIMENTAL

A single oral pill of V3-Myoma therapeutic vaccine containing pooled antigens circulating in peripheral blood and within myoma tissues

Biological: V3-Myoma

Interventions

V3-Myoma BIOLOGICAL

Once daily oral pill of V3-Myoma

Single arm receiving V3-Myoma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Myoma is a female health problem
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• other gynecological diseases not related to myoma hysterectomy

Sponsors & Collaborators

• Immunitor LLC: lead

Study Sites (1)

Immunitor LLC

Ulaanbaatar, Mongolia

RECRUITING

MeSH Terms

Conditions

Myofibroma; Leiomyoma; Fibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neoplasms, Muscle Tissue; Neoplasms, Fibrous Tissue

Study Officials

• Aldar Bourinbaiar, PhD, MD/PhD

  Immunitor LLC

  STUDY CHAIR

Central Study Contacts

Galyna Kutsyna, MD, MD/PhD

CONTACT

+97695130306; kutsynagalyna@yahoo.com

Marina Tarakanovskaya, MD

CONTACT

+97695130306; info@immunitor.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open label, single arm study

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 8, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: July 6, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)