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NCT02010606 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of a Dendritic Cell Vaccine for Patients With Either Newly Diagnosed or Recurrent Glioblastoma
A Phase 1 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT02010606 is a Phase 1 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 39 participants.
The verdict
NCT02010606, a Phase 1 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy
- BIOLOGICAL Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-01-08 |
| Est. Completion | 2021-07-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02010606
The ClinicalTrials.gov registry entry for NCT02010606 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy is the first listed.
NCT02010606 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02010606 about?
NCT02010606 is a clinical study titled "Phase I Study of a Dendritic Cell Vaccine for Patients With Either Newly Diagnosed or Recurrent Glioblastoma". 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 tu...
What is the current status of trial NCT02010606?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2014-01-08. Estimated completion is 2021-07-10.
What interventions are being tested in trial NCT02010606?
The interventions under investigation include: Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy (BIOLOGICAL), Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02010606?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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