Prolonged Exposure to Doxorubicin in Patients With Glioblastoma Multiforme and Diffuse Intrinsic Pontine Glioma
Glioblastoma (GBM), DIPG, Brainstem Glioma, Pediatric
About this trial
This is an interventional treatment trial for Glioblastoma (GBM) focused on measuring glioblastoma multiforme, high grade glioma, diffuse intrinsic pontine glioma, DIPG, doxorubicin, temozolomide, malignant glioma, Brainstem Glioma, diffuse spinal glioma, bilateral thalamic glioma, Anaplastic Astrocytoma, Gliomatosis Cerebri, Midline Diffuse Glioma
Eligibility Criteria
Inclusion Criteria:
- Males and females patients, aged >3 years and < 30 years;
- Newly diagnosed of GBM, DIPG, diffuse brainstem glioma, diffuse spinal glioma, bilateral thalamic glioma, gliomatosis cerebri, anaplastic astrocytoma;
- Patients undergone either surgery or biopsy only;
- No prior chemotherapy and/or radiotherapy;
- Life expectancy ≥ 4 weeks;
- Karnofsky/Lansky ≥ 40 %;
- Written informed consent obtained from the patient/parents or legal representative;
- Adequate hematological function (leucocyte ≥ 2.0 x 10^9/l -Hemoglobin ≥ 10 g/dl - platelet ≥ 50 x 10^9 /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);
- Adherence to trial treatment and compliance with the protocol
Exclusion Criteria:
- Any disease or condition that contraindicates the use of the study drug (es. serious mental retardation, brain palsy, congenital syndrome, cardiomyopathy)
- Prior anti-cancer therapy
- Pregnancy or breastfeeding
- Non adequate contraception
Sites / Locations
- Meyer Children's Hospital
Arms of the Study
Arm 1
Experimental
Doxorubicin
Patients are treated with Weller-Stupp protocol: initial radiotherapy (1.8 Gy/die, days 1-5; total dose 54-60 Gy) with concomitant oral temozolomide (75mg/m2/die, days 1-7) per 6 weeks. At week 10 (4 weeks after the chemo-radiotherapy treatment completion): 1 cycle of oral temozolomide (150-180 mg/m2, days 1-5) At week 14 (8 weeks after the chemo-radiotherapy treatment completion) 1 cycle of prolonged infusion of Doxorubicin (25mg/m2/die in 24 hours, days 1-4; total cumulative dose 100 mg/m2). At week 18 (4 weeks after the end of doxorubicin administration): 16 cycles of oral temozolomide (initial dose of 150 mg/m2 increasing to 180 mg/m2 days 1-5, 28-day cycle). Oral valproic acid (20-30 mg/Kg/die bid) is administered from week 1 until the last treatment day.