Status:
ACTIVE_NOT_RECRUITING
Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Kom Op Tegen Kanker
Stichting Semmy
Conditions:
High Grade Glioma
Diffuse Intrinsic Pontine Glioma
Eligibility:
All Genders
12-17 years
Phase:
PHASE1
PHASE2
Brief Summary
Childhood aggressive gliomas are rare brain tumors with very poor prognosis. Due to the tumor's location and infiltrative nature, surgical removal is not always possible, and even when resection is pe...
Detailed Description
1. Overview of the study treatment scheme 1.1 Newly diagnosed HGG and DIPG patients (stratum A) Patients will be screened and registered in the study following diagnosis, which is based on eit...
Eligibility Criteria
Inclusion
- Diagnosis of
- High grade glioma (WHO grade III or IV), histologically verified
- Diffuse Intrinsic Pontine Glioma, verified by radiologic criteria (magnetic resonance imaging (MRI)) or by histology. A biopsy is not required but recommended.
- Aged ≥ 12 months and \< 18 years at the time of signing the informed consent
- Body weight ≥ 10 kg
- Lansky score (for patients \< 16 years) or Karnofsky score (for patients ≥ 16 years) of ≥ 50
- Reasonable life expectancy ≥ 8 weeks, as estimated by the treating physician
- Adequate hematological blood values and sufficient recovery from treatment-related toxicities (\> grade 1) following previous anti-glioma treatments, as judged by the treating physician
- Written informed consent of parents or legal guardian. Written informed consent of patients aged 12 years or older (written informed consent of patients younger than 12 years is optional).
- Willing and able to comply with the protocol, as judged by the treating physician
- Female patients of child bearing potential must have a negative serum or urine pregnancy test at the time of screening. Female patients of child bearing potential and male patients must agree to use effective contraception before, during and for at least hundred days after the last study treatment administration. Female subjects who are breastfeeding should discontinue nursing prior to the first dose of study treatment and until at least hundred days after the last study treatment administration.
Exclusion
- Use of any investigational agents ≤ 4 weeks before the planned day of leukapheresis.
- Concomitant malignancy or history of another malignancy (unless the Investigator rationalizes otherwise)
- Known concomitant presence of any active immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo
- Any pre-existing contra-indication for contrast-enhanced MRI
- Pregnant or breastfeeding
- 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
Key Trial Info
Start Date :
September 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04911621
Start Date
September 10 2021
End Date
June 1 2027
Last Update
May 8 2024
Active Locations (1)
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1
Unitversity Hospital Antwerp
Edegem, Belgium