20
Participants
Start Date
December 31, 2015
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2025
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"
Antwerp University Hospital, Edegem
University Hospital, Antwerp
OTHER