Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSC-loaded autologous dendritic cells | Experimental | DC-GSC immunotherapy. Six vaccinations are envisaged. The first three vaccinations will be performed every two weeks; subsequent three vaccinations every month. The first vaccination will be performed using 20 million DC, the second and third with 10 million DC; and from the 4th vaccine 5 million DC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSC-loaded autologous dendritic cells | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Probability to obtain the full vaccine dosage, i.e. the percentage of patients who will be treated with at least 2 vaccine injections. | 18 months | |
| Immunologic activity | activity of immunotherapy in terms of its effect on immune response of predefined immune effector cells. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gaetano Finocchiaro, MD | Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 18 months |
| Quality of life | Treatment effect on quality of life will be assessed using the EORTC QLQ-C30 and BN-20. | 18 months |
| Quality of life | Treatment effect on quality of life will be assessed using the BN-20 questionnaire. | 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. | 18 months |