Addition of dendritic-cell vaccination to the treatment of patients with newly diagnosed glioblastoma

Phase 1

• Conditions: ewly diagnosed glioblastoma (WHO grade IV) in adults, treated with surgical resection and chemoradiation; MedDRA version: 20.0Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 100000004865; MedDRA version: 20.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001098-15-BE
• Lead Sponsor: Antwerp University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-23
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Newly diagnosed, histologically verified glioblastoma (WHO grade IV)
- Aged = 18 years
- Total or subtotal resection
- Total resection: macroscopic complete resection as assessed by the neurosurgeon and absence of any residual contrast-enhancing mass on post-operative (= 72h) brain MRI
- Subtotal resection: macroscopic complete resection as assessed by the neurosurgeon, but with residual contrast-enhancement = 2 cm³ on post-operative (= 72h) brain MRI
- Signed informed consent
- Willing and able to comply with the protocol as judged by the Investigator
- Estimated to start with chemoradiation = 28 days and = 49 days following surgical resection
- Fit to undergo: leukapheresis, chemoradiation, chemotherapy and immunotherapy
- No corticosteroid treatment = 1 week before apheresis
- WHO performance status = 2
- Life expectancy = 3 months as estimated by the Investigator
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- History of another malignancy, except for adequately controlled basal cell skin carcinoma, squamous skin carcinoma, or carcinoma in situ of the uterine cervix or unless the investigator rationalizes otherwise
- Prior radiation or chemotherapy
- Any pre-existing contraindication for temozolomide treatment
- Any pre-existing contraindication for contrast-enhanced brain MRI
- Pregnant or breast-feeding
- Documented immune deficiency or systemic immune-suppressive treatment
- Known positive viral serology for HIV, HBV, HCV, or syphilis
- Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified