Metastatic CancerNCT02159937
In Vitro Functional Modulation of Monocyte-derived Dendritic Cells of Patients With Cancer by Peptides
An observational study of Metastatic Cancer, run by Recepta Biopharma at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate in vitro the potential of peptides, to modify, phenotypically and functionally, the monocyte-derived dendritic cells of patients with metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- Blood sampling by vena punction.
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Dec 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed metastatic malignant neoplasia.
Who may be able to join
- Signature of the Informed Consent Form before the performing of any procedures related to the study;
- Age ≥18 years;
- Histologically confirmed metastatic malignant neoplasia;
- Results of laboratorial exams in the first 6 weeks before the blood sample collection within the following values:
- White blood cells ≥ 3.000/μL;
- Platelet count ≥ 100,000/mm³;
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- Hemoglobin > 10g/dL;
- Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and alkaline phosphatase < 2.5 x upper limit of normal (ULN);
- Serum creatinine < 1.5 x upper limit of normal (ULN);
- Karnofsky performance status ≥ 70%.
Who cannot join
- Presence of autoimmune disorders or conditions that require systemic treatment with immunosuppressant medications or systemic corticosteroids;
- Received any systemic chemotherapy or radiotherapy within 15 days prior to the blood sample collection;
- Received any immunotherapy within 4 weeks prior to the blood sample collection;
- Known history of positive serology for HIV (human immunodeficiency virus).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
About this study
The purpose of this study is to evaluate in vitro the potential of peptides, to modify, phenotypically and functionally, the monocyte-derived dendritic cells of patients with metastatic cancer.
Read the detailed description
The DCs will be generated in vitro from peripheral blood mononuclear cells (PBMCs) which will be obtained from 30 ml of peripheral blood collected from each patient with metastatic cancer by venipuncture in heparin tubes.
The cellular viability, the expression of maturation biomarkers and the presence of several cytokines will be evaluated by flow cytometric assays after the culture period of DCs exposed to the peptides.
An interim analysis is programmed with the first 10 patients. If an effect is demonstrated the study will include an additional number of subjects sufficient to ensure adequate comparison with other commercially available peptides.
- Conditions
- Metastatic Cancer
- Being tested
- Blood sampling by vena punction.
- Keywords
- cancer, in vitro, peptides, dendritic cells
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling by vena punction.Other
In vitro tests will be performed after blood sample collection from metastatic cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic cancer | Blood sampling by vena punction. Receives: Other: Blood sampling by vena punction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of cellular markers in the dendritic cells (DCs) after stimulation with the peptides.
Measured: At the seventh day of the cells culture period
Viability of the dendritic cells (DCs) after stimulation with the peptides.
Measured: At the seventh day of the cells culture period
Cytokines production by the dendritic cells (DCs) after stimulation with the peptides.
Measured: At the seventh day of the cells culture period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recepta Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José AM Barbuto, Ph.D, Study chair, Departamento de Imunologia - Instituto de Ciências Biomédicas da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159937
- Sponsor's protocol ID
- PDCX
- Status last verified
- Aug 2015
- First submitted
- 4 Jun 2014
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Functional Modulation of Monocyte-derived Dendritic Cells of Patients With Cancer by Peptides
- ClinicalTrials.gov ID
- NCT02159937
- Acronym / sponsor ID
- PDCX
- Conditions
- Metastatic Cancer
- Keywords
- cancer, in vitro, peptides, dendritic cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Recepta BiopharmaIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Jun 2014 (estimated)
- 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 study is to evaluate in vitro the potential of peptides, to modify, phenotypically and functionally, the monocyte-derived dendritic cells of patients with metastatic cancer.
Detailed description
The DCs will be generated in vitro from peripheral blood mononuclear cells (PBMCs) which will be obtained from 30 ml of peripheral blood collected from each patient with metastatic cancer by venipuncture in heparin tubes.
The cellular viability, the expression of maturation biomarkers and the presence of several cytokines will be evaluated by flow cytometric assays after the culture period of DCs exposed to the peptides.
An interim analysis is programmed with the first 10 patients. If an effect is demonstrated the study will include an additional number of subjects sufficient to ensure adequate comparison with other commercially available peptides.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic cancer | – | Other: Blood sampling by vena punction.Blood sampling by vena punction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed metastatic malignant neoplasia.
Key inclusion criteria (10 listed)
- Signature of the Informed Consent Form before the performing of any procedures related to the study;
- Age ≥18 years;
- Histologically confirmed metastatic malignant neoplasia;
- Results of laboratorial exams in the first 6 weeks before the blood sample collection within the following values:
- Karnofsky performance status ≥ 70%.
Key exclusion criteria (4 listed)
- Presence of autoimmune disorders or conditions that require systemic treatment with immunosuppressant medications or systemic corticosteroids;
- Received any systemic chemotherapy or radiotherapy within 15 days prior to the blood sample collection;
- Received any immunotherapy within 4 weeks prior to the blood sample collection;
- Known history of positive serology for HIV (human immunodeficiency virus).
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 |
|---|---|---|
| Blood sampling by vena punction.In vitro tests will be performed after blood sample collection from metastatic cancer patients | Other | Patients with metastatic cancer |
Primary outcome
Expression of cellular markers in the dendritic cells (DCs) after stimulation with the peptides.
Time frame: At the seventh day of the cells culture period
Viability of the dendritic cells (DCs) after stimulation with the peptides.
Time frame: At the seventh day of the cells culture period
Cytokines production by the dendritic cells (DCs) after stimulation with the peptides.
Time frame: At the seventh day of the cells culture period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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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.
José AM Barbuto, Ph.D study chair
Departamento de Imunologia - Instituto de Ciências Biomédicas da Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer, run by Recepta Biopharma at 1 site in Brazil.
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 10 inclusion and 4 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: finished, as of the sponsor's last update on 5 Aug 2015. 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 Brazil. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Expression of cellular markers in the dendritic cells (DCs) after stimulation with the peptides. (time frame: At the seventh day of the cells culture period). The study lists 3 primary outcomes in all. 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 5 Aug 2015.