Immunotherapy of Cervical Cancer With V3-Cervix

Cervical Cancer Clinical Trial

— V3-Cervix  

Official title:

Open Label Single Arm Phase II Immunotherapy Trial in Patients With Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03550755
• Other study ID #: V3-Cervix-01
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

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Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

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

External Links

•   review on oral vaccines