Key inclusion criteria | Key exclusion criteria |
---|---|
Newly diagnosed, monofocal GBM, isocitrate dehydrogenase wildtype (WHO grade IV; [57]) histologically confirmed by central neuropathologist | Medical history of severe acute or chronic disease with poor prognosis, autoimmune disorder, immunodeficiency, organ allograft or prior malignancy (≤ 3 years) |
Near-complete resection (≤ 5 ml residual tumor volume) confirmed by central neuroradiologist on magnetic resonance imaging (MRI) scan within 72 h postoperative | Infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus or Treponema pallidum or other severe infection requiring hospitalization or i.v. antibiotics or anti-viral treatment (≤ 2 weeks) |
Patients ≥ 18 years of age | Known allergy or intolerability to TMZ or any component of the capsules, dacarbazine, the contrast agent or the DC vaccine |
Karnofsky performance status ≥ 70% | History of bleeding diathesis or coagulopathy |
Sterile tumor sample of ≥ 150 mg with tumor cell frequency ≥ 60%, as determined by central neuropathologist, available for vaccine production | Preexisting myelosuppression |
Successful production of sterile, avital tumor lysate | Previous radiotherapy to head and neck |
Systemic corticosteroids tapered down to ≤ 2 mg of dexamethasone or equivalent per day within 7 days postoperative | Previous (≤ 6 weeks. or ≤ 5 half-lives) treatment with specific immunostimulatory agent |
Adequate hepatic, renal, liver and bone marrow function and blood coagulation | Previous (≤ 4 weeks) treatment with live, attenuated vaccine |
Use of highly effective contraception | Treatment of GBM in another clinical trial with therapeutic intervention or current use of any investigational agent |
Signed informed consent | Known pregnancy or breast-feeding |
O6-methylguanine-DNA-methyltransferase promoter methylation status equivocal |