Safety study of DIPG treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines
- Conditions
- Diffuse intrinsic pontine glioma (DIPG)MedDRA version: 19.0Level: PTClassification code 10006143Term: Brain stem gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003362-84-ES
- Lead Sponsor
- Fundació Sant Joan de Déu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Newly diagnosed DIPG
Patients without progressive disease
Aged between 3 and 18 yo
Lansky scale >50 (Karnosfsky for patients aged more than 16 yr)
Life expectancy > 8 weeks
Preserved bone marrow function
Normal hepatic and renal function
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Impossibility to perform aphaeresis
Patient part of other experimental study within the last 3 months
Patient under antitumor treatment in the last 4 weeks
Co-morbidity that does not allow the study treatment
Patients requiring > 2mg/day of dexametasone treatment
Corticoid-dependent patients
Patients under uncontrolled infection
Positive serologies of HIV, HCV or HBV
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