NCT06297512RecruitingPhase 2
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).
Source: ClinicalTrials.gov · Last updated 7 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 20 Feb 2024
- Start date
- 9 Dec 2022
- Primary completion date
- 9 Nov 2027
- Lead sponsor
- Iacopo Sardi
- Diseases
- Glioblastoma, Childhood cancers
- NCT number
- NCT06297512
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 9 Dec 2022 to the primary completion date, 9 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Performance of a course of 1st-line chemotherapy at the same time as study initiation
- Concurrent participation in other research projects
Other illness
- 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)
Other
- Pregnancy or lactation status
- Use of inappropriate contraceptive methods
Who the study is looking for
- 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
Age in the registry: 3 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Meyer Children's Hospital IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.