Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer

NCT ID: NCT03113019

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-11
• Study Completion Date: 2017-09-11

Brief Summary

The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy method on the basis of autologous antigen-activated dendritic cells in the treatment of patients with breast cancer.

This technology is intended for complex treatment of patients with breast cancer and is aimed at preventing the occurrence and treatment of secondary foci. The need for this technology is justified by the widespread occurrence of breast cancer among women, a decrease in the average age at onset of the disease and a young age, and the chemoresistantness of locally advanced forms of cancer.

Detailed Description

Currently, technologies are being developed to improve the clinical outcomes of patients with complex treatment of breast cancer. Many patients are immunosuppressed after surgical, radiation and chemotherapeutic treatment, which leads to dysfunction of T cells, resulting in tumor cells avoiding immune surveillance. Restoration of antitumor immunity during immunotherapy is one of the modern approaches in the treatment of breast cancer, which contributes to the formation of an effective specific immune response, the destruction of tumor cells while minimizing toxicity. Dendritic cells (DC) and the lymphocytes induced by them are one of the most effective methods for the destruction of residual cancer cells, which are the leading cause of relapse and metastasis.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immunotherapy based on dendritic cells

Intravenous administration dendritic cell and activated mononuclear cells at least 3 times 20-30 million cells / injection

Group Type: EXPERIMENTAL

Immunotherapy based on dendritic cells

Intervention Type: BIOLOGICAL

Intravenous injection of cells

Interventions

Immunotherapy based on dendritic cells

Intravenous injection of cells

Intervention Type: BIOLOGICAL

Other Intervention Names

Dendritic cell vaccine

Eligibility Criteria

Inclusion Criteria

1. For the first time established morphologically confirmed diagnosis of breast cancer

2. patients with II A, II B, IIIA, III B stages of breast cancer;

3. Patients with progressive or primary IV stage of breast cancer with cytologically confirmed and accessible soft tissue metastases;

4. Patients with HER-2 / neu 3 + positive and patients with triple negative breast cancer of the I-II stage (biologically unfavorable forms of breast cancer more prone to recurrence and metastasis).

5. Absence of severe somatic pathology in which medical intervention (at the stage of obtaining biological material or the stage of immunotherapy) will only worsen the patient's condition,

6. The patient's desire.

Exclusion Criteria

1. Pregnancy at any time,

2. Impossibility of correction of therapy of concomitant diseases, if the taken preparations are proved to influence the immune status,

3. Rapid progression of the underlying disease, in which the use of immunotherapy is deontologically unjustified,

4. Individual intolerance to the components of the vaccine and / or the development of severe side effects on any of the components,

5. Refusal of the patient to participate in the study in oral or written form.

6. Patient involvement in any other clinical study (including those that the patient has not been informed by the direct oncologist who has been treated, but which has become known already after the beginning of any stage of the study).

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Research Institute of Fundamental and Clinical Immunology

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergey V. Sennikov, MD

Role: STUDY_DIRECTOR

RIFCI

Other Identifiers

Breast Cancer Lyzate DC

Identifier Type: -

Identifier Source: org_study_id