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

Completed

• Conditions: Metastatic Cancer
• Interventions: Other: Blood sampling by vena punction.

• Registration Number: NCT02159937
• Lead Sponsor: Recepta Biopharma

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with metastatic cancer	Blood sampling by vena punction.	Blood sampling by vena punction.

Primary Outcome Measures

Name	Time	Method
Cytokines production by 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
Expression of cellular markers in the dendritic cells (DCs) after stimulation with the peptides.	At the seventh day of the cells culture period

Trial Locations

Locations (1)

Instituto do Câncer do Estado de São Paulo; 🇧🇷 São Paulo, Brazil