Study of DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer
The primary purpose of the study is to determine the usefullness of new therapy called DCVax®-L in patients who have newly diagnosed GBM and surgery is planned.
Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and temozolomide (Temodar) therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo.
Patients randomized to the placebo arm will have the option to receive DCVax-L in a crossover arm upon documented disease progression.
The study will enroll approximately 300 patients from at least 50 cancer centers in the US and UK.
In addition to other conditions for enrollment, eligible patients have newly diagnosed, unilateral GBM (grade IV).
Participants must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. Patients must also have sufficient DCVax-L product available after manufacturing.
To enroll or if you have questions about participation