Pure Global AI
NCT06297512Recruiting

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).
Iacopo SardiPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Glioblastoma
Drug/Device/Intervention
Radiotherapy, Temozolomide, Doxorubicin
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Iacopo Sardi
Funder
Meyer Children's Hospital IRCCS
Location
Florence, Italy
Timeline & enrollment
Phase
Phase 2
Start date
Dec 09, 2022
End date
Mar 09, 2028
Enrollment
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 brainMalignant neoplasm: Brain, unspecifiedMesotheliomaMalignant neoplasm: Brain stemMalignant neoplasm: Overlapping lesion of brain
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06297512
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.