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

Iacopo Sardi

Status and phase: Enrolling; Phase 2

Conditions: Glioblastoma

Treatments: Drug: Radiotherapy, Temozolomide, Doxorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT06297512

pGBM-WBRT/DOX2020

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 3 to 30 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

pGBM patients therapy

Experimental group

Description:

* Whole therapy radiation therapy * Temozolomide concomitant * After 1 month adjuvant Temozolomide, * After 3 months Doxorubicine * adjuvant Temozolomide

Treatment:

Drug: Radiotherapy, Temozolomide, Doxorubicin