In Vitro Functional Modulation of Monocyte-derived Dendritic Cells of Patients With Cancer by Peptides

August 3, 2015 updated by: Recepta Biopharma
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically confirmed metastatic malignant neoplasia.

Description

Inclusion Criteria:

  1. Signature of the Informed Consent Form before the performing of any procedures related to the study;
  2. Age ≥18 years;
  3. Histologically confirmed metastatic malignant neoplasia;

  4. 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;
    • 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);
  5. Karnofsky performance status ≥ 70%.

Exclusion Criteria:

  1. Presence of autoimmune disorders or conditions that require systemic treatment with immunosuppressant medications or systemic corticosteroids;
  2. Received any systemic chemotherapy or radiotherapy within 15 days prior to the blood sample collection;
  3. Received any immunotherapy within 4 weeks prior to the blood sample collection;
  4. Known history of positive serology for HIV (human immunodeficiency virus).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with metastatic cancer
Blood sampling by vena punction.
Other: Blood sampling by vena punction.
In vitro tests will be performed after blood sample collection from metastatic cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
At the seventh day of the cells culture period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recepta Biopharma

Investigators

  • Study Chair: José AM Barbuto, Ph.D, Departamento de Imunologia - Instituto de Ciências Biomédicas da Universidade de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDCX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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