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

Early Phase 1

• Conditions: Breast Cancer
• Interventions: Biological: Immunotherapy based on dendritic cells

• Registration Number: NCT03113019
• Lead Sponsor: Research Institute of Fundamental and Clinical Immunology

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.

Study Timeline

• Study Start: 2014-02-11
• Primary Completion: 2017-02-11
• Status Verified: 2017-03
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-04-09
• Last Update Submitted: 2017-04-09
• Study First Posted: 2017-04-13
• Last Update Posted: 2017-04-13
• Study Completion: 2017-09-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 26

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunotherapy based on dendritic cells	Immunotherapy based on dendritic cells	Intravenous administration dendritic cell and activated mononuclear cells at least 3 times 20-30 million cells / injection

Primary Outcome Measures

Name	Time	Method
Сytotoxicity	6 months	A study of the cytotoxic activity of peripheral blood mononuclear cells against tumor cells of the MCF-7 line. The result will be presented as the level of cytotoxicity (%) against the cells of the tumor line. The determination of cytotoxicity is carried out using a lactate dehydrogenase test (Promega). The level of the enzyme is proportional to the level of cytotoxicity.

Secondary Outcome Measures

Name	Time	Method
Parameters of peripheral blood	6 months	Leukocyte formula, the enzyme content (lactate dehydrogenase, alkaline phosphatase, liver enzymes) of C-reactive protein, creatinine
Immune status indicators	6 months	We investigated the content of CD 3, CD 4, CD 8, CD 19, CD 16, HLA-DR on CD 14 monocytes
The content of immunosuppressive populations	6 months	We investigated the content of T-regulatory cells, myeloid suppressors, myeloid and plasmacytoid dendritic cells
Interrogation of the patient using a visual analogue scale	6 months	patient evaluates his state in points. The patient is assessed such symptoms as fatigue, irritability, anorexia, nausea, pain, sleep disturbance)
Relapse-free period	36 months	A study of the period between the onset of complex treatment and immunotherapy until the recurrence of the disease.