Actively Recruiting
Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).
Led by Iacopo Sardi · Updated on 2024-03-07
20
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 3 to 30 years with histological-molecular diagnosis of glioblastoma or related tumors according to WHO 2016 classification
- Not previously treated with chemotherapy or radiotherapy, or treated only with surgery
- Life expectancy of at least 12 months
- Karnofsky/Lansky performance status of 80% or higher
- Adequate blood counts: leukocytes 6 2.0 x 10^9/L, hemoglobin 6 10 g/dL, platelets 6 50 x 10^9/L
- Adequate liver function: total bilirubin C= 2.5 x upper limit normal (ULN), ALT/AST C= 5.0 x ULN
- Adequate kidney function: serum creatinine C= 1.5 x ULN
- Written informed consent from patient or legal guardian
- Ability and willingness to comply with study protocol
You will not qualify if you...
- Serious diseases or conditions contraindicating study therapy (e.g., severe mental retardation, severe cerebral palsy, severe congenital syndromes, heart disease)
- Receiving first-line chemotherapy at study start
- Participation in other research projects at the same time
- Pregnancy or breastfeeding
- Use of inadequate contraceptive methods
AI-Screening
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Trial Site Locations
Total: 1 location
1
Meyer Children's Hospital IRCCS
Florence, Italy
Actively Recruiting
Research Team
I
Iacopo Sardi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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