A Phase I Study of Immunotherapy With GSC -Loaded Dendritic Cells in Patients With Recurrent Glioblastoma

Inclusion Criteria:

* Age ≥18 and ≤70 years;
* Histological diagnosis of de novo GBM (i.e. not secondary GBM);
* Gross total resection as evaluated by MRI performed within 72 hours from surgery;
* Karnofsky Performance Status (KPS) ≥60 at the time of first progression;
* Written informed consent.

Exclusion Criteria:

* Pregnancy or breast feeding;
* Participation in other clinical trials with experimental drugs simultaneously;
* Mandatory treatment with corticosteroids or salicylates in anti-inflammatory dose;
* Presence of sub-ependymal diffusion of the tumor;
* Presence of multi-focal GBM lesion;
* Haematology: leukocytes (WBC) \< 3x103/μl, absolute lymphocyte count\< 0.5x103/μl, Absolute neutrophil count (ANC) \< 1x103/μl, hemoglobin\< 9 g/dL, platelets\< 50x103/μl within two days prior to leukapheresis;
* AST (SGOT)/ALT (SGPT) ≥3 X institutional Upper Limit Normal (ULN) at the time of leukapheresis;
* Serum creatinine\>1.5 ULN or calculated creatinine clearance \< 60 ml/min at time of surgery;
* Documented immune deficiency;
* Documented systemic autoimmune disease;
* Positivity for HBV, HIV, HCV, Treponema Pallidum;
* Allergies to any component of the DC vaccine;
* Other active malignancy.