Clinical trial NCT02159937: In Vitro Functional Modulation of Monocyte-derived Dendritic Cells of Patients With Cancer by Peptides
Official title: In Vitro Functional Modulation of Monocyte-derived Dendritic Cells of Patients With Cancer by Peptides
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Cancer
Keywords: cancer
in vitro
peptides
dendritic cells
Lead sponsor: Recepta Biopharma
Sponsor class: INDUSTRY
First posted: 2014-06-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed metastatic malignant neoplasia.

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.

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).

Primary outcomes:
measure: Expression of cellular markers in the dendritic cells (DCs) after stimulation with the peptides.
timeFrame: At the seventh day of the cells culture period
measure: Viability of the dendritic cells (DCs) after stimulation with the peptides.
timeFrame: At the seventh day of the cells culture period
measure: Cytokines production by the dendritic cells (DCs) after stimulation with the peptides.
timeFrame: At the seventh day of the cells culture period
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo
Study officials:
affiliation: Departamento de Imunologia - Instituto de Ciências Biomédicas da Universidade de São Paulo
name: José AM Barbuto, Ph.D
role: STUDY_CHAIR
References: