Paediatric High grade glioma, excluding brain stem gliomas MedDRA version: 16.1 Level: PT Classification code 10065443 Term: Malignant glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Autologous Dendritic cells pulsed with autologous tumour lystate or KLH
Product Code: N/A
Pharmaceutical Form: Injection
INN or Proposed I
Sponsors
Great Ormond Street Hospital for Children NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the feasibility and safety of delivering dendritic cells vaccines to patients in the context of conventional primary treatment (radiotherapy and temozolomide chemotherapy).; Secondary Objective: The secondary objective is the characterisation of immune responses against high grade glioma tumours in patients undergoing dendritic cell vaccinations. • To characterise in detail the cellular and humoral components of the specific anti-tumour immune response in patients with high grade glioma following administration of tumour lysate primed dendritic cell vaccines • To demonstrate that effective T cell immunity is achievable and sustainable in the context of moderate lymphodepletion • To compare the efficacy of different in vitro dendritic cell maturation strategies in producing an immune response; specifically, this trial will examine the role of PGE2 • To determine (in those patients who have a second biopsy or resection) the numbers and function of tumour infiltrating lymphocytes including regulatory T cells and CD8+ T cells A further secondary endpoint is clinical responsiveness. • To accrue clinical data on the safety of the strategy • To collect clinical dat ;Primary end point(s): feasibility and safety of delivering dendritic cells vaccines to patients in the context of conventional primary treatment (radiotherapy and temozolomide chemotherapy). | — |
Countries
United Kingdom
Contacts
Public ContactPraseeda Thaikalloor
Great Ormond Street Hospital
Outcome results
None listed