Trial on efficacy and safety of vaccination of newly diagnosed glioblastoma patients with the patient’s own immune cells.

Phase 1

• Conditions: newly diagnosed glioblastoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000304-14-DE
• Lead Sponsor: Heinrich-Heine-University Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot 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
- 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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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