Evaluating anthracycline treatment after radiotherapy for glioblastoma in young patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effectiveness of combining doxorubicin with whole body radiotherapy and temozolomide in pediatric and young adult patients diagnosed with glioblastoma. The research aims to determine if this combination can improve treatment outcomes compared to standard therapies. The study focuses on patients who have not received prior chemotherapy or radiotherapy, ensuring a clear assessment of the new treatment's impact. By utilizing continuous infusion of doxorubicin, the study also aims to minimize potential cardiotoxicity associated with traditional bolus administration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with histological-molecular diagnosis according to WHO 2016 classification: IDH-wildtype glioblastoma (9440/3), giant cell glioblastoma (9441/3), gliosarcoma (9442/3), epithelioid glioblastoma (9440/3), IDH-mutated glioblastoma (9445/3), glioblastoma NOS (9440/3), diffuse astrocytoma (9400/3), diffuse midline glioma H3 K27M mutated, including multifocal, metastatic or gliomatosis cerebri pictures of first diagnosis Not previously treated (with chemo and radiotherapy) or treated only surgically (total, near partial, partial, biopsy).
* Males and females between the ages of 3 and 30 years old
* Life expectancy ≥ 12 months
* karnofsky/Lansky ≥ 80 %
* Adequate hematologic function: Absolute leukocyte count ≥ 2.0 x 109/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's willingness during treatment and ability to comply with the protocol

Exclusion Criteria:

* Evidence of any other serious disease or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe syndromes congenital syndromes, heart disease)
* Performance of a course of 1st-line chemotherapy at the same time as study initiation
* Concurrent participation in other research projects
* Pregnancy or lactation status
* Use of inappropriate contraceptive methods

Where it's running

• Meyer Children's Hospital IRCCS
  Florence, Italy Recruiting

Study contacts

• Principal investigator: Iacopo Sardi — Meyer Children's Hospital IRCCS
• Study coordinator: Iacopo Sardi
• Email: iacopo.sardi@meyer.it
• Phone: 0555662631

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.