Active — Not RecruitingPhase 1/2

Adjuvant Dendritic Cell-immunotherapy Plus Temozolomide in Glioblastoma Patients

Belgium20 participantsStarted 2015-12

Plain-language summary

In this phase I/II trial, the primary objective is to determine overall and progression-free survival of patients with newly diagnosed glioblastoma when autologous Wilms' tumor 1 (WT1) messenger (m)RNA-loaded dendritic cell (DC) vaccination is added to adjuvant temozolomide maintenance treatment following (sub)total resection and temozolomide-based chemoradiation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines dendritic cell immunotherapy with temozolomide, which is already part of standard glioblastoma treatment — can you help me understand what the dendritic cell vaccine adds, and what is known so far about whether that combination has shown any survival benefit in earlier participants?
2Since this is a Phase 1/2 trial, what does that mean for how much is still unknown about the safety of the dendritic cell immunotherapy component, and what side effects have been reported that I should be aware of?
3The trial is active but no longer enrolling new patients — does that mean there is any possibility of joining, or would you recommend I focus on other trials or standard care options instead?
4The primary goal being measured is overall survival — given where my diagnosis stands right now, how does my situation compare to the kinds of patients who enrolled in this study, and would you expect the results to be relevant to my case?
5Are there other dendritic cell or immunotherapy trials currently open for glioblastoma that might be worth comparing to this one, or is standard temozolomide-based treatment still the stronger path to consider first given what we know?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall survival

Timeframe: Through study completion with follow-up until 90 days after final DC vaccine administration or 24 months after apheresis, whichever occurs later

Trial details

NCT IDNCT02649582

SponsorUniversity Hospital, Antwerp

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

View on ClinicalTrials.gov More Glioblastoma Multiforme of Brain trials