Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 10, 2021

Primary Completion Date

June 1, 2027

Study Completion Date

June 1, 2027

Conditions
High Grade GliomaDiffuse Intrinsic Pontine Glioma
Interventions
BIOLOGICAL

Dendritic cell vaccination + temozolomide-based chemoradiation

"1. Leukocyte apheresis (before chemoradiation): for dendritic cell (DC) vaccine production.~2. Chemoradiation (1st part standard treatment, initiated as soon as the patient's hematological blood values are adequate after apheresis, but no later than 6 weeks after surgery or confirmed diagnosis): 1.8 Gy once daily 5 days/week for 6 weeks with 90 mg/m² temozolomide daily from the first until the last day of radiotherapy.~3. Induction immunotherapy: intradermal vaccination with autologous Wilms' tumor-1 (WT1) mRNA-loaded DCs weekly (-1 day, +2 days) for 3 weeks, starting ≥ 1 week after radiotherapy.~4. Chemo-immunotherapy: 150-200 mg/m²/d temozolomide days 1-5 every 28 days +/- 3 days (max. 6 months, 2nd part standart treatment) starting ≥3 days after the third vaccine of the induction immunotherapy + DC vaccination on day 21±3 days of every 28-day cycle."

BIOLOGICAL

Dendritic cell vaccination +- conventional next-line treatment

"1. Leukocyte apheresis (upon recovery of hematological blood values following previous anti-glioma treatments and ≥ 4 weeks after the last dose of any investigational agent): for DC vaccine production.~2. Induction immunotherapy: intradermal vaccination with autologous WT1 mRNA-loaded DCs weekly (-1 day, +2 days) for 3 weeks, starting ≥ 4 weeks after apheresis.~3. Booster immunotherapy: 6 DC booster vaccinations administered at regular intervals (+- 4 weeks), starting ≥ 3 weeks after the last induction vaccine.~4. (Optional) Concomitant conventional anti-glioma treatment: The decision to continue or re-initiate conventional anti-glioma treatment, and, if applicable, its dose and scheme, are at the Investigator's discretion and will depend on the patient's previous treatment scheme and condition."

Trial Locations (1)

Unknown

Unitversity Hospital Antwerp, Edegem

All Listed Sponsors
collaborator

Kom Op Tegen Kanker

OTHER

collaborator

Stichting Semmy

UNKNOWN

collaborator

Olivia Hendrickx research Fund vzw

UNKNOWN

lead

University Hospital, Antwerp

OTHER