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Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM). - Trial NCT06297512

Access comprehensive clinical trial information for NCT06297512 through Pure Global AI's free database. This Phase 2 trial is sponsored by Iacopo Sardi and is currently Recruiting. The study focuses on Glioblastoma. Target enrollment is 20 participants.

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NCT06297512
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06297512
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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).

Study Focus

Glioblastoma

Radiotherapy, Temozolomide, Doxorubicin

Interventional

drug

Sponsor & Location

Iacopo Sardi

Meyer Children's Hospital IRCCS

Florence, Italy

Timeline & Enrollment

Phase 2

Dec 09, 2022

Mar 09, 2028

20 participants

Primary Outcome

Evaluation prolonged Dox,Percentage of Withdrawal from the study rate,Percentage of SAEs,Mortality rate,Early discontinuation of dox treatment rate

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

ICD-10 Classifications

Malignant neoplasm of brain
Malignant neoplasm: Brain, unspecified
Mesothelioma
Malignant neoplasm: Brain stem
Malignant neoplasm: Overlapping lesion of brain

Data Source

ClinicalTrials.gov

NCT06297512

Non-Device Trial