Patients with newly diagnosed glioblastoma which can be resected up to a (sub)total extent. MedDRA version: 13.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 13.1 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: DCm-HGG-L
Product Code: DC
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intradermal use
Sponsors
University Hospital Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with glioblastoma multiforme, which was at least subtotally resected, of which the largest part is kept dry and sterile at -80°C, if the patient could be weaned from corticosteroids within 7 days after operation 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: • Pregnancy • Patients with postoperative Karnofsky index < 70 • Simultaneous treatment according to other clinical trials • Virus serology positive for Hepatitis B/C, syphilis, HTLV or HIV • Blood counts: Leukocytes < 3000/µl, lymphocytes < 500/µl, neutrophils < 1000/µl, hemoglobin < 9 g/100 ml, thrombocytes < 100000/µl at day 10, about 2 days prior to leukapheresis • Documented immune deficiency • Documented autoimmune disease • Mandatory treatment with corticosteroids or salicylates in inflammatory dose • Other active malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if the Progression-free survival at the end of 6 cycles TMZm can be improved by DC-based immunotherapy incorporated in standard treatment of high grade glioma at diagnosis;Secondary Objective: • To evaluate the efficacy of induction of an immune response after versus during maintenance chemotherapy • To assess the overall survival of treated patients compared to historical controls • To assess quality of life during immunotherapy ;Primary end point(s): The primary endpoint is the blinded evaluation of the PFS after 6 cycles of TMZm, which will be compared between both treatment arms (week 36). | — |
Countries
Belgium
Outcome results
None listed