Breast CancerEarly Phase 1BC-LDCNCT03113019
Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer
A Early Phase 1 study testing Immunotherapy based on dendritic cells in people with Breast Cancer, run by Research Institute of Fundamental and Clinical Immunology.
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. Read more about this study
- Who is it for?
- Ages 28 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Immunotherapy based on dendritic cells
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2014to 11 Sep 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Immunotherapy based on dendritic cells
- Keywords
- dendritic cell, IL-12, IL-18, сytotoxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy based on dendritic cellsBiological
Also called Dendritic cell vaccine
Intravenous injection of cells
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy based on dendritic cells | Experimental | Intravenous administration dendritic cell and activated mononuclear cells at least 3 times 20-30 million cells / injection Receives: Biological: Immunotherapy based on dendritic cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Parameters of peripheral blood
Leukocyte formula, the enzyme content (lactate dehydrogenase, alkaline phosphatase, liver enzymes) of C-reactive protein, creatinine
Measured: 6 months
Immune status indicators
We investigated the content of CD 3, CD 4, CD 8, CD 19, CD 16, HLA-DR on CD 14 monocytes
Measured: 6 months
The content of immunosuppressive populations
We investigated the content of T-regulatory cells, myeloid suppressors, myeloid and plasmacytoid dendritic cells
Measured: 6 months
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)
Measured: 6 months
Relapse-free period
A study of the period between the onset of complex treatment and immunotherapy until the recurrence of the disease.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start11 Feb 2014
- Primary completion11 Feb 2017
- Study completion11 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Fundamental and Clinical Immunology
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey V. Sennikov, MD, Study director, RIFCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113019
- Sponsor's protocol ID
- Breast Cancer Lyzate DC
- Acronym
- BC-LDC
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03113019
- Acronym / sponsor ID
- BC-LDC / Breast Cancer Lyzate DC
- Conditions
- Breast Cancer
- Keywords
- dendritic cell, IL-12, IL-18, сytotoxicity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Research Institute of Fundamental and Clinical ImmunologyOther government
- Study start
- 11 Feb 2014 (actual)
- Primary completion
- 11 Feb 2017 (actual)
- Study completion
- 11 Sep 2017 (estimated)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy based on dendritic cells | Experimental | Biological: Immunotherapy based on dendritic cellsIntravenous administration dendritic cell and activated mononuclear cells at least 3 times 20-30 million cells / injection |
Who may qualify
- Ages
- 28 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunotherapy based on dendritic cellsAlso: Dendritic cell vaccineIntravenous injection of cells | Biological | Immunotherapy based on dendritic cells |
Primary outcome
Сytotoxicity
Time frame: 6 months
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.
5 secondary outcomes
Parameters of peripheral blood
Time frame: 6 months
Immune status indicators
Time frame: 6 months
The content of immunosuppressive populations
Time frame: 6 months
Interrogation of the patient using a visual analogue scale
Time frame: 6 months
Relapse-free period
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey V. Sennikov, MD study director
RIFCI
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Immunotherapy based on dendritic cells in people with Breast Cancer, run by Research Institute of Fundamental and Clinical Immunology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Сytotoxicity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.