Recruitment

Recruitment Status
Completed
Estimated Enrollment
30

Inclusion Criteria

Histologically confirmed metastatic malignant neoplasia;
Serum creatinine < 1.5 x upper limit of normal (ULN);
White blood cells ≥ 3.000/μL;
...
Histologically confirmed metastatic malignant neoplasia;
Serum creatinine < 1.5 x upper limit of normal (ULN);
White blood cells ≥ 3.000/μL;
Signature of the Informed Consent Form before the performing of any procedures related to the study;
Platelet count ≥ 100,000/mm³;
Hemoglobin > 10g/dL;
Age ≥18 years;
Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and alkaline phosphatase < 2.5 x upper limit of normal (ULN);
Karnofsky performance status ≥ 70%.

Exclusion Criteria

Presence of autoimmune disorders or conditions that require systemic treatment with immunosuppressant medications or systemic corticosteroids;
Received any immunotherapy within 4 weeks prior to the blood sample collection;
Known history of positive serology for HIV (human immunodeficiency virus).
...
Presence of autoimmune disorders or conditions that require systemic treatment with immunosuppressant medications or systemic corticosteroids;
Received any immunotherapy within 4 weeks prior to the blood sample collection;
Known history of positive serology for HIV (human immunodeficiency virus).
Received any systemic chemotherapy or radiotherapy within 15 days prior to the blood sample collection;

Summary

Conditions
Metastatic Cancer
Type
Observational
Design
  • Observational Model: Case-Only
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 presen...

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.

Inclusion Criteria

Histologically confirmed metastatic malignant neoplasia;
Serum creatinine < 1.5 x upper limit of normal (ULN);
White blood cells ≥ 3.000/μL;
...
Histologically confirmed metastatic malignant neoplasia;
Serum creatinine < 1.5 x upper limit of normal (ULN);
White blood cells ≥ 3.000/μL;
Signature of the Informed Consent Form before the performing of any procedures related to the study;
Platelet count ≥ 100,000/mm³;
Hemoglobin > 10g/dL;
Age ≥18 years;
Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and alkaline phosphatase < 2.5 x upper limit of normal (ULN);
Karnofsky performance status ≥ 70%.

Exclusion Criteria

Presence of autoimmune disorders or conditions that require systemic treatment with immunosuppressant medications or systemic corticosteroids;
Received any immunotherapy within 4 weeks prior to the blood sample collection;
Known history of positive serology for HIV (human immunodeficiency virus).
...
Presence of autoimmune disorders or conditions that require systemic treatment with immunosuppressant medications or systemic corticosteroids;
Received any immunotherapy within 4 weeks prior to the blood sample collection;
Known history of positive serology for HIV (human immunodeficiency virus).
Received any systemic chemotherapy or radiotherapy within 15 days prior to the blood sample collection;

Tracking Information

NCT #
NCT02159937
Collaborators
Not Provided
Investigators
Study Chair: José AM Barbuto, Ph.D Departamento de Imunologia - Instituto de Ciências Biomédicas da Universidade de São Paulo
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