Trials / Completed
CompletedNCT02820584
A Phase I Study of Immunotherapy With GSC -Loaded Dendritic Cells in Patients With Recurrent Glioblastoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSC-loaded autologous dendritic cells |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2016-07-01
- Last updated
- 2019-09-12
Source: ClinicalTrials.gov record NCT02820584. Inclusion in this directory is not an endorsement.