MedTrace Logo

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

NCT04523688 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-07-22

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

Autologous Dendritic Cells (DC) vaccine

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

DRUG

Temozolomide

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).

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Laura Ridolfi, DR · IRST IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523688 on ClinicalTrials.gov