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

de Novo Glioblastoma Clinical Trial

— DENDR-STEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820584
• Other study ID #: DENDR-STEM
• Status: Completed
• Phase: Phase 1
• Start date: September 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2019
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• de Novo Glioblastoma
• Glioblastoma

Intervention

Biological:
• GSC-loaded autologous dendritic cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: - incidence, nature, severity and seriousness of AEs, according to NCI-CTCAE version 4.0; - maximum toxicity grade and percentage of patients experiencing grade 3-4 by each patient for each specific toxicity; - patients with at least a SAE.	Safety will be assessed as follows: Incidence, nature, severity and seriousness of AEs, according to NCI-CTCAE, version 4.0; Maximum toxicity grade experienced by each patient for each specific toxicity; Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity; Patients with at least a SAE; Patients with at least a SADR; Patients with at least a Suspected Unexpected Serious Associated Reaction (SUSAR).	18 months
Primary	Incidence, severity and type of AEs throughout the study, and toxicities will be graded according to the National Cancer Institute Common Toxicity Criteria for AE (CTCAE), version 4.0		18 months
Secondary	Probability to obtain the full vaccine dosage, i.e. the percentage of patients who will be treated with at least 2 vaccine injections.		18 months
Secondary	Immunologic activity	activity of immunotherapy in terms of its effect on immune response of predefined immune effector cells.	18 months
Secondary	Progression free survival (PFS)	Progression Free Survival after immunotherapy is defined for each patient as the time of onset of immunotherapy to the date of second progression.	18 months
Secondary	Quality of life	Treatment effect on quality of life will be assessed using the EORTC QLQ-C30 and BN-20.	18 months
Secondary	Quality of life	Treatment effect on quality of life will be assessed using the BN-20 questionnaire.	18 months
Secondary	Overall survival (OS)	Overall Survival after immunotherapy is defined for each patient as the time of onset of immunotherapy to the date of death from any cause.	18 months