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

NCT02159937 | Completed

• 1 other identifier: PDCX
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Cancer

Keywords

cancer; in vitro; peptides; dendritic cells

Outcome Measures

Primary Outcomes (3)

• Expression of cellular markers in the dendritic cells (DCs) after stimulation with the peptides.

  At the seventh day of the cells culture period

• Viability of the dendritic cells (DCs) after stimulation with the peptides.

  At the seventh day of the cells culture period

• Cytokines production by the dendritic cells (DCs) after stimulation with the peptides.

  At the seventh day of the cells culture period

Study Arms (1)

Patients with metastatic cancer

Blood sampling by vena punction.

Other: Blood sampling by vena punction.

Interventions

Blood sampling by vena punction. OTHER

In vitro tests will be performed after blood sample collection from metastatic cancer patients

Patients with metastatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed metastatic malignant neoplasia.

You may qualify if:

• 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;
• 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%.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Recepta Biopharma: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• José AM Barbuto, Ph.D

  Departamento de Imunologia - Instituto de Ciências Biomédicas da Universidade de São Paulo

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 10, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

BR (1)