A Phase II Feasibility Study of Adjuvant Intra-Nodal Autologous Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme
Two to six weeks after surgery, patients with newly diagnosed glioblastoma multiforme (GBM)
will undergo a six-week course of radiotherapy with concurrent chemotherapy (temozolomide).
Between three and seven weeks after completing radiotherapy/chemotherapy, patients will
undergo leukapheresis to collect white blood cells. These cells will be grown into
dendritic cells, and cultured with tumor cells from the individual patient. Vaccinations
will be given every two weeks for a total of three vaccinations. Four weeks after the third
vaccination patients will resume chemotherapy for one year or until disease progression.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor-specific Cytotoxic T-cell Response
MRI & pheresis post vaccine
Camilo E. Fadul, MD
Dartmouth-Hitchcock Medical Center
United States: Food and Drug Administration
|Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756|