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A Phase I Study of Immunotherapy With GSC -Loaded Dendritic Cells in Patients With Recurrent Glioblastoma (DENDR-STEM)
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.
Details
| Lead sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2016-09 |
| Completion | 2017-06 |
Conditions
- de Novo Glioblastoma
Interventions
- GSC-loaded autologous dendritic cells
Primary outcomes
- 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. — 18 months
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). - 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