Efficacy & Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme After Complete Surgical Resection
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      1. Primary outcome measure:

           a.Evaluation of the treatment impact on progression-free survival.

        2. Secondary outcome measures:

             1. Safety evaluation.

                  -  Direct effects attributable cell obtaining and administration.

                  -  Adverse events during treatment.

                  -  Neurological deterioration quantified using the NIH Stroke Scale.

                  -  Autoimmune phenomena.

             2. Evaluation of impact on other efficiency clinical parameters.

                  -  Overall survival.

                  -  Quality of life measured with EORTC questionnaire.

             3. Study of specific immune response and correlates with clinical outcome.

                  -  Delayed hypersensitivity.

                  -  Humoral response to autologous tumor cells/tumoral lysate.

                  -  Cellular response (proliferation, cytokine production, specific cytotoxicity).

             4. Cell line characterization and correlate the final product with clinical efficacy.

                  -  Phenotypic studies.
    

Detailed description: 
      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.
    

Intervention name(s): autologous dendritic cells
Intervention type(s): Biological
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glioblastoma multiforme, vaccine, dendritic cells, glioma