Immunotherapy using patient-derived dendritic cells for glioblastoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of autologous tumor lysate-loaded dendritic cells as an immunotherapy approach for patients with newly diagnosed glioblastoma multiforme. The treatment protocol includes radical surgical resection of the tumor, followed by radiotherapy and chemotherapy, after which patients will receive a series of dendritic cell vaccinations designed to stimulate an immune response against residual tumor cells. The trial aims to evaluate the safety and efficacy of this innovative immunotherapy in conjunction with standard treatment protocols.

Why it matters

Who can join: the full rules

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.

Where it's running

• UOC Neuro-oncologia Molecolare
  Milano, Italy Recruiting

Study contacts

• Study coordinator: Marica Eoli, MD
• Email: marica.eoli@istituto-besta.it
• Phone: +022394

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.