Phase I Study of a Dendritic Cell Vaccine for Patients With Either Newly Diagnosed or Recurrent Glioblastoma
Summary
The purpose of this study is to test the safety and effects of a special type of a cancer vaccine called a 'dendritic cell vaccine' in patients with either newly diagnosed or recurrent glioblastoma. The goal of this dendritic cell vaccine is to activate a patient's own immune system against their tumor. This study utilizes a patient's own immune-stimulating dendritic cells that are isolated in a procedure called leukapheresis. In a laboratory, these dendritic cells are treated in a way that is designed to promote an immune response against cancer stem cells. Then the dendritic cells are injected under the skin in a series of vaccinations, with the goal of activating an immune response against cancer stem cells in the tumor. To qualify for this study, patients must have very little to no residual tumor visible on a recent MRI. In addition to the vaccines, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation therapy. Patients with recurrent glioblastoma will not receive any treatment other than the vaccines as long as they are participating in this study, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab.
Timeline
- Start
- 2014-01-08
- Primary completion
- 2019-01-23
- Completion
- 2021-07-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DC vaccine | Vaccine | — | Subcutaneous |
| Background | Bevacizumab | Monoclonal antibody | — | — |
| Background | Temozolomide | Small molecule | — | — |