Actively Recruiting
Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2025-07-22
28
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed monofocal glioblastoma
- Near-complete tumor resection with residual volume less than or equal to 5 ml confirmed by MRI or CT scan within 72 hours after surgery
- Karnofsky performance status of 70% or higher, or ECOG performance status of 0 or 1
- Willing and able to provide written informed consent
- Age 18 years or older at time of consent
- Life expectancy greater than 12 weeks
- Suitable for leukapheresis collection with negative serological tests for HIV, hepatitis B and C, and Treponema pallidum
- Candidate for standard radiochemotherapy (Stupp regimen)
- Appropriate 12-lead ECG and echocardiogram
- Availability of sufficient leukapheresis material for vaccine preparation
- No progressive disease after radiochemotherapy
- Recovery from previous treatment side effects to grade 1 or less by CTCAE 5.0
- Adequate organ and marrow function
You will not qualify if you...
- Diagnosis of immunodeficiency or receiving systemic steroid therapy above 10 mg prednisone equivalent or other immunosuppressive therapy within 7 days before first dose
- Active autoimmune disease requiring systemic treatment within past 2 years
- Known history of active tuberculosis
- Previous treatment with a cancer vaccine
- Other malignant cancers with disease-free interval less than 5 years, except certain skin and cervical cancers
- Positive serology for Treponema pallidum, hepatitis B, hepatitis C, or HIV
- Received a live vaccine within 30 days before starting study therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy, 47014
Actively Recruiting
Research Team
O
Oriana Nanni, DR
CONTACT
A
Anna Miserocchi, DR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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