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

Recepta Biopharma

Status: Completed

Conditions: Metastatic Cancer

Treatments: Other: Blood sampling by vena punction.

Study type: Observational

Funder types: Industry

Identifiers

NCT02159937

PDCX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

33 participants in 1 patient group

Patients with metastatic cancer

Description:

Blood sampling by vena punction.

Treatment:

Other: Blood sampling by vena punction.