The standard therapy of glioblastoma (GBM) consists of gross total resection followed by focal irradiation to the tumor bed with concomitant and adjuvant temozolomide (TMZ). The association of valproic acid and TMZ during radiotherapy improves survival of GBM. Preclinical studies suggested that doxorubicin had a strong antineoplastic activity against human gliomas. Moreover, some studies showed that the continuous infusion of anthracyclines in patients with solid tumor ensured a better safety profile compared with bolus administration. Based on these findings, the purpose of this study is to evaluate safety and efficacy of prolonged administration of doxorubicin in combination with radiotherapy, temozolomide and valproic acid in pediatric and adult patients with newly diagnosed GBM and diffuse intrinsic pontine glioma (DIPG).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Meyer Children's Hospital
Florence, Italy
Time to early discontinuation of the study drug (doxorubicin)
Time frame: 6 months
Number of participants with treatment-related serious adverse events (SAE) as assessed by CTCAE v4.0
Number of patients with SAE and SAE leading to withdrawal from the study
Time frame: 32 months
Number of patients who died for SAE as assessed by CTCAE v4.0
Mortality due to adverse events
Time frame: 32 months
Number of patients who undergone to withdrawal of doxorubicin
Rate of early suspension of the study drug (doxorubicin)
Time frame: 6 months
Event free survival
Event free survival (EFS) defined as time (days) between the date of enrolment and the earliest occurence of anyone of the following: progression based on RECIST 1.1 criteria; tumor recurrence; death to any cause.
Time frame: 2 months
Overall survival
Overall survival (OS) defined as time between the date of the enrolment and the death to any cause
Time frame: 2 months
Progression free survival
Progression free survival (PFS) defined as time between the date of the enrolment and the date tumor progression based on RECIST 1.1criteria
Time frame: 2 months
Rate of treatment response
Rate of treatment response (CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease) based on RECIST 1.1 criteria
Time frame: 2 months
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