Glioblastoma Multiforme
Conditions
Interventions
Product Name: NA
Product Code: NA
Pharmaceutical Form: Suspension for injection
Trade Name: Temodal
Pharmaceutical Form:
Sponsors
Masaryk University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Female or male, aged between 18 and 70 years (at time of diagnosis) •Glioblastoma multiforme (WHO IV), proven by reference histology •Total, subtotal or partial resection of more than 70% of tumour mass defined by MRI •Tumour localisation: Brain or spinal cord, except diffuse intrinsic brain-stem glioma •Life expectancy of at least 12 weeks by assessment of the attending physician •Written informed consent of patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Positivity for blood transmitted diseases - HIV, HBV, HCV or syphilis. •Partial resection of less than 70% of tumour mass defined by MRI •Corticosteroid treatment necessary within five days before leukocyte apheresis •Diffuse brain-stem glioma •Insufficient amount of tumour tissue available for vaccine production •Anti-neoplastic chemotherapy or radiotherapy (brachy- or teletherapy) prior to enrollment •Poor clinical condition •Pregnancy or nursing •Evidence of an active infectious disease or active autoimmune disease •Participation on another therapeutic Phase I, II or III study at least 4 weeks before entering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary purpose of the clinical trial is to evaluate the feasibility and toxicity of dendritic cell vaccination in patients with newly diagnosed glioblastoma multiforme treated with surgical resection, irradiation and oral chemotherapy with temozolomide.;Secondary Objective: •Progression-free survival (PFS) 6 months after diagnosis of glioblastoma multiforme. •Overall survival (OS) in patients with glioblastoma multiforme. •Immune response demonstrated by delayed type hypersensitivity (DTH) testing before, during and after the vaccination course, and by testing specific immune response in an in-vitro T-lymphocyte assay. •Quality of life in patients treated with DC vaccination. ;Primary end point(s): Toxicity of DC vaccination | — |
Countries
Czech Republic
Outcome results
None listed