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Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM). | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).

Interventional, Single-arm, Open-label Open-label, Phase II Trial to Evaluate the Role of Anthracycline Infusion After Radio Therapy (RT) in Pediatric and Young Adults With Glioblastoma (pGBM).

NCT06297512•Iacopo Sardi

View on ClinicalTrials.gov

Summary

Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB

Eligibility

Age

3 - 30 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Meyer Children's Hospital IRCCS

Florence, Italy

Key Dates

Start Date

December 9, 2022

Primary Completion Date

November 9, 2027

Completion Date

March 9, 2028

Last Updated

March 7, 2024

Enrollment

ESTIMATED participants

Conditions

Glioblastoma

Interventions

Radiotherapy, Temozolomide, Doxorubicin

DRUG

Contacts

Iacopo Sardi

CONTACT

0555662631 iacopo.sardi@meyer.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Targeted Pediatric High-Grade Glioma Therapy

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