RecruitingPhase 2NCT04523688

Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma

Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma: a Phase II Study

Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Enrollment

28 participants

Start Date

Mar 25, 2021

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Vaccination

Summary

Single arm, monocentric trial to assess the safety and the progression-free survival related to the combined treatment of dendritic cell vaccine loaded with autologous tumor homogenate and temozolomide in patients operated for glioblastoma and then treated with standard radiochemotherapy (according to Stupp regimen).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine made from a patient's own immune cells (dendritic cells) loaded with material from their own tumor, given after standard radiation and chemotherapy for glioblastoma — the most aggressive type of brain tumor. **You may be eligible if...** - You have been diagnosed with glioblastoma (a type of brain cancer) confirmed by biopsy - Your tumor is a single, localized tumor (not multifocal) - You are able to undergo standard initial treatment (radiation plus temozolomide chemotherapy) - You have adequate immune cells that can be collected for vaccine manufacturing **You may NOT be eligible if...** - Your tumor is in an inoperable location or involves multiple areas of the brain - You have significant immune system problems - You are on high-dose steroids that would prevent effective immune response Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous Dendritic Cells (DC) vaccine

10×10exp6 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)

DRUGTemozolomide

Adjuvant temozolomide assumed orally from day 1 to 5 (start on week 5). Dosage: 150mg/m2/day for the first cycle and 200 mg/m2/day for subsequent cycles (q28).