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

NCT03113019 | Unknown Early Phase 1

• 1 other identifier: Breast Cancer Lyzate DC
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Parameters of peripheral blood

  6 months

• Immune status indicators

  6 months

• The content of immunosuppressive populations

  6 months

• Interrogation of the patient using a visual analogue scale

  6 months

• Relapse-free period

  36 months

Study Arms (1)

Immunotherapy based on dendritic cells

EXPERIMENTAL

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

Biological: Immunotherapy based on dendritic cells

Interventions

Immunotherapy based on dendritic cells BIOLOGICAL

Intravenous injection of cells

Also known as: Dendritic cell vaccine

Immunotherapy based on dendritic cells

Eligibility Criteria

• Age: 28 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Research Institute of Fundamental and Clinical Immunology: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sergey V. Sennikov, MD

  RIFCI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 13, 2017
• Study Start: February 11, 2014
• Primary Completion: February 11, 2017
• Study Completion: September 11, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share