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

NCT ID: NCT02159937

Last Updated: 2015-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-12-31

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with metastatic cancer

Blood sampling by vena punction.

Blood sampling by vena punction.

Intervention Type: OTHER

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

Interventions

Blood sampling by vena punction.

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Recepta Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José AM Barbuto, Ph.D

Role: STUDY_CHAIR

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

Locations

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

PDCX

Identifier Type: -

Identifier Source: org_study_id