Phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy in newly diagnosed glioblastoma

Phase 2

Recruiting

Conditions: C71
Malignant neoplasm of brain

Registration Number: DRKS00013248

Lead Sponsor: Heinrich-Heine-Universität Düsseldorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 136

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
•Karnofsky performance status (KPS) = 70%
•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 within 7 days postoperative
•Adequate hepatic, liver and bone marrow function and blood coagulation
•Signed informed consent

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) or Trepo-nema pallidum or other severe infection requiring treatment
•Known allergy or intolerability to components of vaccine, to TMZ or to dacarbazine
•History of bleeding diathesis or coagulopathy
•O6-methylguanine-DNA-methyltransferase (MGMT) promoter methylation status equivocal

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival as measured from the day of surgery until death

Secondary Outcome Measures

Name	Time	Method
•Progression-free survival 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<br>•OS and PFS rates at 6, 12 and 24 months after the day of surgery<br>•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) <br>•Overall and neurological performance based on the Karnofsky performance status and the Minimal Mental State Examination 2 (MMSE-2)<br>•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<br>