Back to results

Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer (BC-LDC)

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

Immunotherapy based on dendritic cells

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring dendritic cell, IL-12, IL-18, сytotoxicity

Eligibility Criteria

28 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

For the first time established morphologically confirmed diagnosis of breast cancer
patients with II A, II B, IIIA, III B stages of breast cancer;
Patients with progressive or primary IV stage of breast cancer with cytologically confirmed and accessible soft tissue metastases;
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).
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,
The patient's desire.

Exclusion Criteria:

Pregnancy at any time,
Impossibility of correction of therapy of concomitant diseases, if the taken preparations are proved to influence the immune status,
Rapid progression of the underlying disease, in which the use of immunotherapy is deontologically unjustified,
Individual intolerance to the components of the vaccine and / or the development of severe side effects on any of the components,
Refusal of the patient to participate in the study in oral or written form.
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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immunotherapy based on dendritic cells

Arm Description

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

Outcomes

Primary Outcome Measures

Сytotoxicity

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

Parameters of peripheral blood

Leukocyte formula, the enzyme content (lactate dehydrogenase, alkaline phosphatase, liver enzymes) of C-reactive protein, creatinine

Immune status indicators

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

We investigated the content of T-regulatory cells, myeloid suppressors, myeloid and plasmacytoid dendritic cells

Interrogation of the patient using a visual analogue scale

patient evaluates his state in points. The patient is assessed such symptoms as fatigue, irritability, anorexia, nausea, pain, sleep disturbance)

Relapse-free period

A study of the period between the onset of complex treatment and immunotherapy until the recurrence of the disease.

Full Information

NCT ID

NCT03113019

First Posted

March 21, 2017

Last Updated

April 9, 2017

Sponsor

Research Institute of Fundamental and Clinical Immunology

1. Study Identification

Unique Protocol Identification Number

NCT03113019

Brief Title

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

Acronym

BC-LDC

Official Title

Investigation of the Clinical and Laboratory Efficacy of Autogemotherapy Based on Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 11, 2014 (Actual)

Primary Completion Date

February 11, 2017 (Actual)

Study Completion Date

September 11, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Research Institute of Fundamental and Clinical Immunology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

dendritic cell, IL-12, IL-18, сytotoxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Patients with breast cancer receive a cellular preparation consisting of dendritic cells loaded with tumor lysate antigens and activated mononuclear cells. Patients receive this treatment in the adjuvant mode at IIa-IIIc stages and in neoadjuvant regimen with progression or 4 stages of the disease

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immunotherapy based on dendritic cells

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Immunotherapy based on dendritic cells

Other Intervention Name(s)

Dendritic cell vaccine

Intervention Description

Intravenous injection of cells

Primary Outcome Measure Information:

Title

Сytotoxicity

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Parameters of peripheral blood

Description

Leukocyte formula, the enzyme content (lactate dehydrogenase, alkaline phosphatase, liver enzymes) of C-reactive protein, creatinine

Time Frame

6 months

Title

Immune status indicators

Description

We investigated the content of CD 3, CD 4, CD 8, CD 19, CD 16, HLA-DR on CD 14 monocytes

Time Frame

6 months

Title

The content of immunosuppressive populations

Description

We investigated the content of T-regulatory cells, myeloid suppressors, myeloid and plasmacytoid dendritic cells

Time Frame

6 months

Title

Interrogation of the patient using a visual analogue scale

Description

patient evaluates his state in points. The patient is assessed such symptoms as fatigue, irritability, anorexia, nausea, pain, sleep disturbance)

Time Frame

6 months

Title

Relapse-free period

Description

A study of the period between the onset of complex treatment and immunotherapy until the recurrence of the disease.

Time Frame

36 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

28 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For the first time established morphologically confirmed diagnosis of breast cancer patients with II A, II B, IIIA, III B stages of breast cancer; Patients with progressive or primary IV stage of breast cancer with cytologically confirmed and accessible soft tissue metastases; 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). 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, The patient's desire. Exclusion Criteria: Pregnancy at any time, Impossibility of correction of therapy of concomitant diseases, if the taken preparations are proved to influence the immune status, Rapid progression of the underlying disease, in which the use of immunotherapy is deontologically unjustified, Individual intolerance to the components of the vaccine and / or the development of severe side effects on any of the components, Refusal of the patient to participate in the study in oral or written form. 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sergey V. Sennikov, MD

Organizational Affiliation

RIFCI

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs