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Clinical trial to evaluate the effects of chemotherapy with anthracycline, after radiotherapy, in a group of pediatric and young adult patients with glioblastoma
EU CTIS ID: 2024-519135-41-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
- Perform a 1st line chemotherapy cycle at the same time as the start of the study
- Simultaneous participation in other research projects
- State of pregnancy or breastfeeding
- Use of inadequate contraceptive methods
See the full eligibility criteria
- 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
- 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)
- Perform a 1st line chemotherapy cycle at the same time as the start of the study
- Simultaneous participation in other research projects
- State of pregnancy or breastfeeding
- Use of inadequate contraceptive methods
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.