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Brain cancer vaccine shows promise in early trial

NCT ID NCT04801147

Disease control Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a personalized vaccine made from a patient's own tumor cells and immune cells (dendritic cells) for people with newly diagnosed glioblastoma, an aggressive brain cancer. The goal was to see if the vaccine is safe and can help delay tumor growth. 76 participants received the vaccine after standard surgery and chemoradiation. The treatment aims to train the immune system to attack remaining cancer cells, potentially improving outcomes without major side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2010

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years and ≤70 years. * Postoperative Karnofsky Performance Status ≥70. * First diagnosis of GBM (World Health Organization \[WHO\] grade IV astrocytoma). * Diagnosis confirmed by the reference histopathology. * Residual tumor volume after resection \<10 cc, confirmed by postoperative MRI assessment * Total or subtotal resection of tumor mass, confirmed by assessment of the neurosurgeon and by postoperative radiological assessment. * Amount of non-necrotic tissue for lysate preparation and DC loading ≥1 gr, stored at -80°C. * Corticosteroids daily dose ≤4 mg during the 2 days prior to leukapheresis. * Clinical indication for radiochemotherapy according to the Stupp protocol (Stupp et al., 2005). * Life expectancy \> 3 months. * Informed consent Exclusion Criteria: * Pregnancy. * Participation in other clinical trials with experimental drugs simultaneously or within 1 month before this trial entry. * Presence of acute infection requiring active treatment. * Mandatory treatment with corticosteroids or salicylates in anti-inflammatory dose. * Presence of sub-ependymal diffusion of the tumor. * Presence of multi-focal GBM lesions. * Haematology: leukocytes \< 3,000/μl, lymphocytes \< 500/μl, neutrophils \< 1,000/μl, hemoglobin \<9 g/100 ml, thrombocytes \< 100,000/μl one or two days prior to leukapheresis. * Documented immune deficiency. * Documented autoimmune disease. * Positive serology for HIV, HBs antigen, HCV, TPHA. * Allergies to any component of the DC vaccine. * Known intolerance to TMZ. * Other active malignancy.

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Conditions

The condition(s) this trial relates to.

glioblastoma glioma susceptibility 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glioblastoma

Contacts and locations

Locations

  • UOC Neuro-oncologia Molecolare

    Milan, Milano, 20133, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.