University Hospital and DCVax-L Trial In Cologne Germany
DCVax-L Trial in Germany at University Hospital of Cologne, Department of General Neurosurgery is getting close showing "IN PLANNING" as noted below
Phase II clinical study evaluating DCVax ®-L Brain - autologous dendritic cells loaded with tumor lysate antigen for the treatment of glioblastoma multiforme (GBM).
Patients aged 18 to 70 with first-diagnosed glioblastoma (heavy grade IV), according to the protocol can be included in the study. Patients who have received radiotherapy with concurrent Temodar ® chemotherapy according to the Stupp protocol (Stupp et al, N Engl J Med 352:. 987-96, 2005) and no evidence of disease progression after radiation therapy are entitled to in the study were randomized to are. All patients must have a Karnofsky performance score (KPS) of = 70 and must meet a projected life expectancy of at least 8 weeks have. Patients should also have in the last 5 years no tumor history and no active infection.
The patient two intradermal injections of DCVax ®-L Brain or autologous MNC (placebo) administered per treatment. Each of the two injections must be at least 1.25 million dendritic cells per 0.15 ml of solution containing application. The injection is given into the upper arm. The cellular therapeutic agent is administered at 0, 10 and 20 days as well as after 2, 4, 8, 12, 18, 24 and 30 months. All cross-over patients to the treatment regimen received the active immune vaccination in unison, provided the event that sufficient DCVax ®-L Brain is available.
Contact: Dr. P. Stavrinou, Dr. C. Wetzel, Dr. C. Bauer, P. Schulte