Dendritic cell vaccine immunotherapy in paediatric high grade glioma
- Conditions
- Paediatric High grade glioma, excluding brain stem gliomasMedDRA version: 16.1 Level: PT Classification code 10065443 Term: Malignant glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-018447-34-GB
- Lead Sponsor
- Great Ormond Street Hospital for Children NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
• Histologically confirmed high-grade glioma (including anaplastic astrocytoma, glioblastoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma and anaplastic variants of ganglioglioma and pleomorphic xanthoastrocytoma)
• Substantial debulking surgery (primary treatment or relapse group) or small volume recurrence (relapse group).
• Available tumour lysate for DC pulsing
• Informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
• Brain stem glioma
• Metastatic spinal disease
• Uncorrected hydrocephalus
• Other ongoing chemotherapy
• Positive serology for HIV, Hepatitis B or C, or positive TPHA test (syphilis)
• Auto-immune disease (presence of autoantibodies in standard screen plus clinical features consistent with presence of antibodies)
• Lansky/Karnovsky score less than 40 unless lower due to surgery
• Pregnancy
• Grade 4 CTC toxicity in any of the following categories
o Cardiac
o Infection
o Dermatology/skin
o Renal
o Gastrointestinal (excluding anorexia)
o Pain
o Neurological (excluding sensory and audiological)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method