Adjuvant Dendritic Cell-immunotherapy Plus Temozolomide in Glioblastoma Patients

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Glioblastoma Multiforme of Brain
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"

Trial Locations (1)

2650

Antwerp University Hospital, Edegem

All Listed Sponsors
lead

University Hospital, Antwerp

OTHER

NCT02649582 - Adjuvant Dendritic Cell-immunotherapy Plus Temozolomide in Glioblastoma Patients | Biotech Hunter | Biotech Hunter