Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma
Recruiting now · Phase 2
Conditions studied: Glioblastoma, Vaccination
In brief
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).
Key facts
- Study ID
- NCT04523688
- Run by
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- People needed
- 28
- Starts
- 2021-03-25
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy > 10 mg prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a known history of active Bacillus Tuberculosis (TB)
- Previous treatment with a cancer vaccine
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years, except basal or squamous cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with radical surgery.
- Any known history of or is positivity of any serologic marker indicative of infection by Treponema pallidum, hepatitis B virus (HBsAg, HBsAb, HBcAB), hepatitis C virus (HCVAb, HCV RNA quantitative), human immunodeficiency virus (HIV), whether actual or previous.
- Has received a live vaccine within 30 days of planned start of study therapy.
Where it is running
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) — Meldola, FC, Italy (enrolling)
Full record on ClinicalTrials.gov
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