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

Study Purpose

Mono-center, un-controlled, open label, first in human, clinical trial. Approximately 20 patients (in order to achieve 12 valuable patients). The expected accrual time would range between 12 and 18 months. Follow-up, including clinical, immune and radiological monitoring will end two years after the initial surgery of the last patient enrolled. The primary objective will be to assess the activity of immunotherapy in terms of its effect on immune response. In particular we will investigate the effect of treatment on effector cells including CD8 T cells, NK cells and Natural Killer T (NKT) cells. The sample size of 12 eligible patients was identified on ethical and practical considerations, rather than by a formal sample size calculation.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02820584
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Gaetano Finocchiaro, MD
Principal Investigator Affiliation	Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Completed
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	de Novo Glioblastoma

Arms & Interventions

Arms

Experimental: GSC-loaded autologous dendritic cells

DC-GSC immunotherapy. Six vaccinations are envisaged. The first three vaccinations will be performed every two weeks; subsequent three vaccinations every month. The first vaccination will be performed using 20 million DC, the second and third with 10 million DC; and from the 4th vaccine 5 million DC

Interventions

Biological: - GSC-loaded autologous dendritic cells

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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