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
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring dendritic cell, IL-12, IL-18, сytotoxicity
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).
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
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
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.
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
No
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
No
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Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer
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