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

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03113019
• Other study ID #: Breast Cancer Lyzate DC
• Status: Active, not recruiting
• Phase: Early Phase 1
• First received: March 21, 2017
• Last updated: April 9, 2017
• Start date: February 11, 2014
• Est. completion date: September 11, 2017

Study information

• Verified date: March 2017
• Source: Research Institute of Fundamenta and Clinical Immunology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: September 11, 2017
• Est. primary completion date: February 11, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 28 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• Immunotherapy based on dendritic cells
Intravenous injection of cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute of Fundamenta and Clinical Immunology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?ytotoxicity	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	Parameters of peripheral blood	Leukocyte formula, the enzyme content (lactate dehydrogenase, alkaline phosphatase, liver enzymes) of C-reactive protein, creatinine	6 months
Secondary	Immune status indicators	We investigated the content of CD 3, CD 4, CD 8, CD 19, CD 16, HLA-DR on CD 14 monocytes	6 months
Secondary	The content of immunosuppressive populations	We investigated the content of T-regulatory cells, myeloid suppressors, myeloid and plasmacytoid dendritic cells	6 months
Secondary	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)	6 months
Secondary	Relapse-free period	A study of the period between the onset of complex treatment and immunotherapy until the recurrence of the disease.	36 months