newly diagnosed glioblastoma
Conditions
Interventions
Product Name: dendritic cell vaccine
Product Code: GlioVax
Pharmaceutical Form: Suspension for injection
Sponsors
Heinrich-Heine-University Düsseldorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - newly diagnosed, monofocal GBM, IDH wildtype (WHO grade IV) confirmed by central neuropathology review - near-complete resection (= 5 ml residual tumor volume) confirmed by central neuroradiologist on magnetic resonance imaging (MRI) scan within 72 h postoperative - patients = 18 years of age - Karnofsky performance status (KPS) = 70% or = 50% and minimal mental state examination = 25 - sterile tumor sample of = 150 mg with tumor cell frequency = 60% as determined by central neuropathologist available for vaccine production - successful production of sterile, avital tumor lysate - systemic corticosteroids tapered down to = 2 mg of dexa-methasone or equivalent per day at baseline - adequate hepatic, liver and bone marrow function and blood coagulation - signed informed consent 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 213 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 213
Exclusion criteria
Exclusion criteria: - medical history of severe acute or chronic disease with poor prognosis, autoimmune disorder, immunodeficiency or organ allograft - infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis E (HEV) or Treponema pallidum or other severe infection requiring treatment -known allergy or intolerability to components of vaccine, to TMZ or to dacarbazine - severe myelosuppression - history of bleeding diathesis or coagulopathy - O6-methylguanine-DNA-methyltransferase (MGMT) promoter methylation status equivocal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine whether overall survival of newly diagnosed GBM patients treated with lysate-loaded, mature dendritic cell vaccines as add-on to the standard of care consisting of resection, radiotherapy with concomitant temozolomide chemotherapy and subsequent adjuvant temozolomide chemotherapy is superior to the treatment with the standard of care alone;Secondary Objective: Secondary objectives are comparing progression-free survival and 6, 12 and 24 month OS and PFS rates, the safety profile, overall and neurological performance and the quality of life between the two treatment groups;Primary end point(s): The primary efficacy endpoint is overall survival (OS) measured from the day of surgery until death.;Timepoint(s) of evaluation of this end point: from day of surgery until death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - progression-free survival (PFS) as measured from the day of surgery until diagnosis of tumor progression by MRI scan according to modified Response Assessment in Neuro-Oncology (RANO) criteria or death due to any cause - OS and PFS rates at 6, 12 and 24 months after the day of surgery - safety based on the frequency and severity of adverse events (AE) with toxicity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events 4.03 (CTCAE 4.03) - overall and neurological performance based on the Karnofsky performance status and the Minimal Mental State Examination 2 (MMSE-2) - quality of life as determined by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 3.0 and Brain Cancer Module QLQ-BN20 as well as the Distress Thermometer (DT) and the Hospital Anxiety and Depression Scale (HADS) for psycho-oncological strain assessment;Timepoint(s) of evaluation of this end point: 6, 12 and 24 months after the day of surgery | — |
Countries
Germany
Contacts
Public ContactDepartment of Neurosurgery
University Hospital Center Düsseldorf
Outcome results
None listed