2024-519135-41-00Active, not recruitingPhase 2
Clinical trial to evaluate the effects of chemotherapy with anthracycline, after radiotherapy, in a group of pediatric and young adult patients with glioblastoma
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- 21 Jun 2022
- Lead sponsor
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Diseases
- Childhood cancers, Glioblastoma
- EU CT number
- 2024-519135-41-00
- EudraCT number
- 2020-005131-74
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Perform a 1st line chemotherapy cycle at the same time as the start of the study
Other illness
- 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)
Other
- Simultaneous participation in other research projects
- State of pregnancy or breastfeeding
- Use of inadequate contraceptive methods
Who the study is looking for
- 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
Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Meyer IRCCS | Florence | Italy | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.