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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03550755
Other study ID # V3-Cervix-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2018
Est. completion date December 31, 2019

Study information

Verified date August 2019
Source Immunitor LLC
Contact Galyna Kutsyna, MD, MD/PhD
Phone +97695130306
Email kutsynagalyna@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this trial is to evaluate the efficacy of immunotherapy for cervical cancer based on a fundamentally new approach. We will test new tableted preparation, V3-Cervix, obtained from hydrolyzed, inactivated blood and tumors of patients with cervical cancer. When administered orally, it should cause a specific anti-tumor immune response and an anti-inflammatory effect. Trial is planned to last 3 months, recruit 20 volunteers, administer daily pill of vaccine and evaluate effect on tumor size and tumor markers.


Description:

Cervical cancer (CC) is a malignant neoplasm that occurs in the cervix. Histologically, there are two main types: adenocarcinoma and squamous cell carcinoma. Cervical cancer is most common in middle-aged women (35-55 years of age), in 20% of cases it is found over the age of 65 years. Cancer of the body and cervix are the most common type of malignant tumor of female genital organs. It is believed that human papillomavirus (HPV) is the main risk factor causing cervical cancer. Cervical cancer combines surgical treatment, radiotherapy and chemotherapy. Current immunotherapies did not show much success. The prognosis depends on the stage of the disease: 5-year survival rate at the first stage is 78.1%, at the second stage - 57%, at the third - 31%, at the fourth - 7.8%. There is no specific cervical cancer marker, usually a panel of markers is used including CA125, beta-hCG, CEA, SCC, CA19.9 and CA27.29. The goal of this trial is to evaluate the efficacy of immunotherapy for cervical cancer based on a fundamentally new approach. We will test new tableted preparation, V3-Cervix, obtained from hydrolyzed, inactivated blood and tumors of patients with cervical cancer. When administered orally, it should cause a specific anti-tumor immune response and an anti-inflammatory effect. Trial is planned to last 3 months, recruit 20 volunteers, administer daily pill of vaccine and evaluate effect on tumor size and tumor markers.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

confirmed diagnosis of cervical cancer available baseline measurement of tumor size and burden presence of tumor markers associated with cervical cancer, i.e., CA125, beta-hCG, CEA, SCC, ??19.9 and ??27.29 -

Exclusion Criteria:

metastases to other sites hysterectomy

-

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
V3-Cervix
Oral tableted preparation containing hydrolyzed tumor antigens derived from peripheral blood and tumor tissue

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 Changes in tumor size and burden compared to baseline Intravaginal ultrasonography of lower abdomen to measure changes monthly for 3 months
Secondary Effect on baseline tumor markers, if any Change in serum levels of a panel of tumor markers such as CA125, beta-hCG, CEA, SCC, ??19.9 and ??27.29 compared to baseline Monthly for three months
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