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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159937
• Other study ID #: PDCX
• Status: Completed
• Phase: N/A
• First received: June 4, 2014
• Last updated: August 3, 2015
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Recepta Biopharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Other:
• Blood sampling by vena punction.
In vitro tests will be performed after blood sample collection from metastatic cancer patients

Locations

Country	Name	City	State
Brazil	Instituto do Câncer do Estado de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Recepta Biopharma

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of cellular markers in the dendritic cells (DCs) after stimulation with the peptides.		At the seventh day of the cells culture period	No
Primary	Viability of the dendritic cells (DCs) after stimulation with the peptides.		At the seventh day of the cells culture period	No
Primary	Cytokines production by the dendritic cells (DCs) after stimulation with the peptides.		At the seventh day of the cells culture period	No