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Table 1 Inclusion and exclusion criteria

From: A randomized controlled phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy of newly diagnosed glioblastoma (GlioVax): study protocol for a randomized controlled trial

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
  1. Legend: DC dendritic cell, GBM glioblastoma multiforme, i.v. intravenous, TMX temozolomide, WHO World Health Organization