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ACTIVE NOT RECRUITING
NCT02649582
PHASE1/PHASE2

Adjuvant Dendritic Cell-immunotherapy Plus Temozolomide in Glioblastoma Patients

Sponsor: University Hospital, Antwerp

View on ClinicalTrials.gov

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.

Official title: Adjuvant Dendritic-Cell Immunotherapy Plus Temozolomide Following Surgery and Chemoradiation in Patients With Newly Diagnosed Glioblastoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2015-12

Completion Date

2025-12

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

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

Locations (1)

Antwerp University Hospital

Edegem, Antwerp, Belgium