Prospective, Phase II Clinical Trial to Evaluate Efficacy and Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme Patients After Complete Surgical Resection With Fluorescence Microscope
A prospective, open-label, unicentric phase II trial, historical control and non-randomized.
The study will try to evaluate the efficiency and safety of the experimental treatment using
a cell therapy product (tumor lysate-pulsed autologous dendritic cell vaccine) in patients
with glioblastoma multiforme in whom a gross total resection is feasible. Patients will
receive standard first-line therapy (surgery before radio-chemotherapy) along with the
experimental treatment. The experimental treatment consists in subcutaneous vaccination with
a suspension of autologous dendritic cells (cells from the same patient) produced by cell
culture from monocytes from the same patient extracted by leukapheresis and pulsed with a
lysate of the patient´s tumoral tissue. The first four vaccines will be administered on a
monthly basis, concomitantly with the standard chemo and radiotherapy treatments, the next
four vaccines, every other month and the four last vaccinations every three months.The
results obtained will be compared with those of an historical control study, where patients
received a standard treatment without the experimental vaccine.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of the treatment impact on progression-free survival
5 years
No
Felipe Prosper, MD, PhD
Study Director
Clinica Universidad de Navarra
Spain: Spanish Agency of Medicines
DEND/GM
NCT01006044
October 2009
June 2014
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