A Phase I/II Clinical Trial of Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients (click here to view detailed trial description)
This is a phase 2, non-randomized, open-label trial.
There are 3 arms: first, a dose expansion study to find the maximum tolerated dose of the CMV-specific T-cells in recurrent GBM at first relapse, along with dose-dense temozolomide.
After finding the maximum tolerated dose, the second arm of recurrent GBM patients undergoes temozolomide treatment for 21 days followed by the first administration of CMV-specific T-cells, followed by surgery for the recurrent tumor on day 30. After surgery patients undergo another 3 cycles of dose-dense temzolomide followed by T-cell infusions. Temozolomide is continued for a maximum of 12 cycles or until disease progression.
The third arm consists of newly diagnosed GBM patients treated with dose-dense temozolomide and CMV-specific T-cells, after conventional radiochemotherapy.
All patients undergo a leukapheresis procedure to obtain T-cells, which are reinjected after conditioning.
Very similar to the Duke DC PP65 Vaccine which attempts to inform/teach body's T-Cells that a CMV protein is the "enemy" and should be attacked by immune system. If the Seattle study indicating GBM almost always contains CMV, this vaccine should be successful.
ReplyDeletehttps://www.sciencedaily.com/releases/2017/04/170414105842.htm?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+sciencedaily%2Fhealth_medicine%2Fbrain_tumor+%28Brain+Tumor+News+--+ScienceDaily%29
ReplyDeleteAlthough the trial was small and not designed to evaluate efficacy, four of the 11 study patients survived for more than five years following treatment with a combination of vaccine and the drug temozolomide, a first-line chemotherapy drug for glioblastoma.
Batich and colleagues -- including senior author John Sampson, M.D., Ph.D., chair of Duke's Department of Neurosurgery -- treated 11 patients as part of a single arm study to test the safety of using a dose-intensified regimen of temozolomide along with a dendritic cell vaccine therapy that selectively targets a cytomegalovirus (CMV) protein.