Colorectal CancerEarly Phase 1NCT03214939
Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Colorectal Cancer
A Early Phase 1 study testing Immunotherapy based on dendritic cells in people with Colorectal Cancer, run by Research Institute of Fundamental and Clinical Immunology at 1 site in Russia.
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 colorectal cancer. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Immunotherapy based on dendritic cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 27 Sep 2016to Sep 2019
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the first time established morphologically confirmed diagnosis of colorectal cancer
- Patients with II A, II B, II C, III A, III B, III C stages of colorectal cancer;
- Patients with progressive or primary IV stage of colorectal cancer with cytologically confirmed and accessible soft tissue metastases;
- 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).
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
RIFCI
Novosibirsk
Sergey V. Sennikov, MD, sennikov@gmail.com
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 Colorectal 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 colorectal cancer.
This technology is intended for complex treatment of patients with colorectal 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 colorectal cancer, a decrease in the average age at onset of the disease, 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 colorectal 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 colorectal 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
- Colorectal Cancer
- Being tested
- Immunotherapy based on dendritic cells
- Keywords
- dendritic cell, IL-12, IL-18, cytotoxicity
- Medical subject headings
- Colorectal 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
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 COLO 320 HSR 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 investigate the content of CD 3+, CD 4+, CD 8+, CD 19+, CD 16+/56+ cells, HLA-DR on CD 14 monocytes
Measured: 6 months
The content of immunosuppressive populations
We investigate 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
The 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 posted12 Jul 2017
- Study start27 Sep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 colorectal cancer receive a cellular preparation consisting of dendritic cells loaded with tumor lysate antigens and activated mononuclear cells.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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
- NCT03214939
- Sponsor's protocol ID
- Colorectal cancer lysate DC
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 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 Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03214939
- Acronym / sponsor ID
- Colorectal cancer lysate DC
- Conditions
- Colorectal Cancer
- Keywords
- dendritic cell, IL-12, IL-18, cytotoxicity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Research Institute of Fundamental and Clinical ImmunologyOther government
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 12 Jul 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 colorectal cancer.
This technology is intended for complex treatment of patients with colorectal 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 colorectal cancer, a decrease in the average age at onset of the disease, 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 colorectal 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 colorectal 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 colorectal cancer receive a cellular preparation consisting of dendritic cells loaded with tumor lysate antigens and activated mononuclear cells.
| 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
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For the first time established morphologically confirmed diagnosis of colorectal cancer
- Patients with II A, II B, II C, III A, III B, III C stages of colorectal cancer;
- Patients with progressive or primary IV stage of colorectal cancer with cytologically confirmed and accessible soft tissue metastases;
- 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.
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 cellsIntravenous 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 COLO 320 HSR 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 12 Jul 2017.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Immunotherapy based on dendritic cells in people with Colorectal Cancer, run by Research Institute of Fundamental and Clinical Immunology at 1 site in Russia.
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 5 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 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Ekaterina V. Kulikova, PhD (+8(383) 222-19-10, homchek@gmail.com), or a site near the patient. 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 12 Jul 2017.