Clinical trial NCT03113019: Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer
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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: dendritic cell, IL-12, IL-18, сytotoxicity
Lead sponsor: Research Institute of Fundamental and Clinical Immunology
Sponsor class: OTHER_GOV
First posted: 2017-04-13
Enrollment: 26
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Сytotoxicity
timeFrame: 6 months
Secondary outcomes:
measure: Parameters of peripheral blood
timeFrame: 6 months
measure: Immune status indicators
timeFrame: 6 months
measure: The content of immunosuppressive populations
timeFrame: 6 months
measure: Interrogation of the patient using a visual analogue scale
timeFrame: 6 months
measure: Relapse-free period
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: RIFCI
name: Sergey V. Sennikov, MD
role: STUDY_DIRECTOR
References: