Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Belgium / NCT02649582
Active, not recruiting Phase 1/2

Adjuvant Dendritic Cell-immunotherapy Plus Temozolomide in Glioblastoma Patients

NCT02649582 · tracked via the Priya Life Science Belgium tracker
Sponsor
University Hospital, Antwerp
Phase
Phase 1/2
Started
2015-12
Last updated
2026-06-04

Condition(s) studied

Glioblastoma Multiforme of Brain

Investigational drug(s) / intervention(s)

Dendritic cell vaccine plus temozolomide chemotherapy →

Dendritic cell vaccine plus temozolomide chemotherapy: When eligible after total or subtotal resection (as assessed by neurosurgeon and post-operative brain MRI): 1. Leukocyte apheresis (before chemoradiation): for DC vaccine production 2. Chemoradiation (standard treatment: initiated as soon as the patient's hematological blood values are adequate after apheresis): 2 Gy once daily 5 days/week for 6 weeks with 75 mg/m² temozolomide daily from the first until the last day of radiotherapy (no longer than 49 days in total) 3. Induction immunotherapy: intradermal vaccination with autologous WT1 mRNA-loaded DCs weekly (+/-1 day) for 3 weeks, starting ≥ 1 week after radiotherapy 4. Chemo-immunotherapy: 150-200 mg/m²/d temozolomide days 1-5 every 28 days +/- 2 days (max. 12 months) starting ≥3 days after the third vaccine of the induction immunotherapy + DC vaccination on day 21±3 days of every 28-day cycle

Study summary

In this phase I/II trial, the primary objective is to determine overall and progression-free survival of patients with newly diagnosed glioblastoma when autologous Wilms' tumor 1 (WT1) messenger (m)RNA-loaded dendritic cell (DC) vaccination is added to adjuvant temozolomide maintenance treatment following (sub)total resection and temozolomide-based chemoradiation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Newly diagnosed, histologically verified glioblastoma (WHO grade IV) * Aged ≥ 18 years * Total or subtotal resection: * Total resection: macroscopic complete resection as assessed by the neurosurgeon and absence of any residual contrast-enhancing mass on post-operative (≤ 72h) brain MRI * Subtotal resection: macroscopic complete resection as assessed by the neurosurgeon, but with residual contrast-enhancement ≤ 2 cm³ on post-operative (≤ 72h) brain MRI * Signed informed consent * Willing and able to comply with the protocol as judged by the Investigator * Estimated to start with chemoradiation ≥ 28 days and ≤ 49 days following surgical resection * Fit to undergo: leukapheresis, chemoradiation, chemotherapy and immunotherapy * No corticosteroid treatment ≤ 1 week before apheresis * WHO performance status ≤ 2 * Life expectancy ≥ 3 months as estimated by the Investigator Exclusion Criteria: * History of another malignancy, except for adequately controlled basal cell skin carcinoma, squamous skin carcinoma, or carcinoma in situ of the uterine cervix or unless the investigator rationalizes otherwise * Prior radiation or chemotherapy * Any pre-existing contraindication for temozolomide treatment * Any pre-existing contraindication for contrast-enhanced brain MRI * Pregnant or breast-feeding * Documented immune deficiency or systemic immune-suppressive treatment * Known positive viral serology for HIV, HBV, HCV, or syphilis * Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications

Primary outcome measure(s)

  • Overall survival — Through study completion with follow-up until 90 days after final DC vaccine administration or 24 months after apheresis, whichever occurs later
    Patients will be followed for survival, from apheresis (\~ diagnosis), for which the accurate date and reason of death (cancer-related or non-related) will be recorded for every patient.

Trial sites (1)

FacilityCityRegionStatus
Antwerp University Hospital Edegem Antwerp

More University Hospital, Antwerp trials in Belgium

CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS Recruiting
Compairing R-ICNB and C-ICNB for Postoperative Pain Management After Minimal-invasive Anatomical Lung Resection Active, not recruiting
The Maggie Project: Exploring the Origin and Heredity of the Vaginal Microbiome Recruiting
Collection of Liquid Biopsy Samples of Neuroendocrine Neoplasms (NEN) Patients - Collection of NET (CollectNET) 2.0, a Study by the BE-FORCE Consortium Recruiting
Multicenter Ventral Mesh Rectopexy Registry Collaborative Recruiting

Other trials for the same condition

The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) Recruiting
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma Recruiting
The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02649582 on ClinicalTrials.gov ↗ ← All trials in Belgium