Clinical trial to evaluate the effects of chemotherapy with anthracycline, after radiotherapy, in a group of pediatric and young adult patients with glioblastoma
Key facts
- Where
- Florence, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Trial code
- EU 2024-519135-41-00
- Record updated
- 2026. július 28.
- Original description
To evaluate the safety and tolerability of prolonged administration of doxorubicin in combination with radiotherapy and temozolomide in pediatric and young adult patients with gliobastomaRead full original descriptionShow less
Phase II, single-arm, open-label interventional clinical trial to evaluate the role of anthracycline infusion after radiotherapy (RT) in pediatric and young adult patients with glioblastoma (pGBM)
To evaluate the safety and tolerability of prolonged administration of doxorubicin in combination with radiotherapy and temozolomide in pediatric and young adult patients with gliobastoma
Inclusion: Patients with histological-molecular diagnosis according to WHO 2016 classification: Glioblastoma IDH-wildtype (9440/3), giant cell glioblastoma (9441/3), gliosarcoma (9442/3), epithelioid glioblastoma (9440/3), IDH glioblastoma mutant (9445/3), NOS glioblastoma (9440/3), diffuse astrocytoma (9400/3), diffuse midline glioma H3 K27M mutated, including multifocal, metastatic, or previously untreated gliomatosis cerebri contextes (with chemo and radiotherapy) or treated only surgically (total, almost partial, partial, biopsy); Males and females between the ages of 3 and 30; Life expectancy > or = 12 months; Karnofsky/Lansky > o = 80%; Adequate haematological function: Absolute white blood cell count >= 2.0 x 10^9 /l; Hemoglobin >= 10 g/dl; Platelet count >= 50 x 109/l; Adequate liver function: Total bilirubin <= 2.5 x ULN; ALT / AST <= 5.0 x ULN; Adequate renal function: Serum creatinine <= 1.5 x ULN; Written informed consent from the patient, parents or legal guardians; Patient availability during treatment and ability to comply with the protocol.
Exclusion: Perform a 1st line chemotherapy cycle at the same time as the start of the study; Evidence of any other serious illness or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe congenital syndromes, heart disease); Simultaneous participation in other research projects; State of pregnancy or breastfeeding; Use of inadequate contraceptive methods.