Mono-center, un-controlled, open label, first in human, clinical trial. Approximately 20 patients (in order to achieve 12 valuable patients). The expected accrual time would range between 12 and 18 months. Follow-up, including clinical, immune and radiological monitoring will end two years after the initial surgery of the last patient enrolled. The primary objective will be to assess the activity of immunotherapy in terms of its effect on immune response. In particular we will investigate the effect of treatment on effector cells including CD8 T cells, NK cells and Natural Killer T (NKT) cells. The sample size of 12 eligible patients was identified on ethical and practical considerations, rather than by a formal sample size calculation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Safety: - incidence, nature, severity and seriousness of AEs, according to NCI-CTCAE version 4.0; - maximum toxicity grade and percentage of patients experiencing grade 3-4 by each patient for each specific toxicity; - patients with at least a SAE.
Safety will be assessed as follows: * Incidence, nature, severity and seriousness of AEs, according to NCI-CTCAE, version 4.0 * Maximum toxicity grade experienced by each patient for each specific toxicity * Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity * Patients with at least a SAE * Patients with at least a SADR * Patients with at least a Suspected Unexpected Serious Associated Reaction (SUSAR).
Time frame: 18 months
Incidence, severity and type of AEs throughout the study, and toxicities will be graded according to the National Cancer Institute Common Toxicity Criteria for AE (CTCAE), version 4.0
Time frame: 18 months
Probability to obtain the full vaccine dosage, i.e. the percentage of patients who will be treated with at least 2 vaccine injections.
Time frame: 18 months
Immunologic activity
activity of immunotherapy in terms of its effect on immune response of predefined immune effector cells.
Time frame: 18 months
Progression free survival (PFS)
Progression Free Survival after immunotherapy is defined for each patient as the time of onset of immunotherapy to the date of second progression.
Time frame: 18 months
Quality of life
Treatment effect on quality of life will be assessed using the EORTC QLQ-C30 and BN-20.
Time frame: 18 months
Quality of life
Treatment effect on quality of life will be assessed using the BN-20 questionnaire.
Time frame: 18 months
Overall survival (OS)
Overall Survival after immunotherapy is defined for each patient as the time of onset of immunotherapy to the date of death from any cause.
Time frame: 18 months
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