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.