Glioblastoma brain tumors MedDRA version: 19.0 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Autologous cancer stem cell mRNA transfected dendritic cells
Product Code: DEN-STEM
Pharmaceutical Form: Suspension for injection
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following conditions must apply: 1. Must be at least 18 years and less than 70 years of age. 2. Must be ambulatory with a ECOG performance status 0 or 1 3. Must have histologically confirmed glioblastoma IDH wild type, with non-methylated MGMT-gene promotor, and a candidate for combined radiation therapy and chemotherapy (“Stupps Regimen”). 4. Must have accessible volume and quality of tumor tissue for vaccine production (proliferation of cells and extraction of tumor mRNA). 5. Must have postoperative MRI after surgery with contrast enhancing tumor remnant of less than 1 cm3 or less than 10% of original tumor volume. 6. Normal organ function defined by laboratory values. 7. Glucocorticosteroids should be minimized or stopped before starting given vaccination. 8. Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose. Reliable methods of contraception are defined in section 8.8. 9. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Tumor in a localization where a modest increase in size due to reactive oedema may have a large impact on the patient’s neurological condition, i.e. brain stem. 2. Large tumor remnant. 3. History of prior malignancy other than glioblastoma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervicis stage IB. 4. Active infection requiring antibiotic therapy. 5. Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia. 6. Prior splenectomy. 7. Glucocorticoid treatment not possible to terminate due to autoimmune disease or increased intracranial pressure. 8. Adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions. 9. History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome. 10. Chemotherapy or other potentially immune-suppressive therapy outside protocol that has been administered within the last 4 weeks prior to vaccination. 11. Any reason why, in the opinion of the investigator, the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the therapeutic effect of the product on progression free survival in glioblastoma patients. ;Secondary Objective: To identify the effect of the product on overall survival, patient reported quality of life, immunological response and to identify adverse events. ;Primary end point(s): Progression free survival - Defined as time from first surgery to first certain progress of contrast enhancing tumor or clinical progression, according to the Response Assessment in Neuro-Oncology (RANO) criteria. Assessment of objective tumor response includes an evaluation by MRI at the start of vaccination, at week 25 and thereafter every 3 months. As contrast enhancement may vary over time, due to pseudoprogression and may be affected through the course of the immune-therapy, the definite time of progression may be corrected after overall survival has been reached. ;Timepoint(s) of evaluation of this end point: Progression free survival will be evaluated after all patients have finished treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival - Defined as the time from first surgery to death. Patient reported quality of life – Evaluated by EORTC QLQ-C30 and QLQ-BN20. Immunological response – Evaluated by Delayed Type Hypersensitivity (DTH) reactions and in vitro T-cell proliferation and cytokine response assays. Adverse events – According to the Common Terminology Criteria for Adverse Event (CTCEA version 4.0) criteria;Timepoint(s) of evaluation of this end point: Adverse events will be followed continuously, all other secondary end points will be evaluated after all patients have finished treatment. | — |
Countries
Norway
Contacts
Public ContactTrial manager
Oslo University Hospital
Outcome results
None listed