Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM).

Condition(s) studied

Investigational drug(s) / intervention(s)

Radiotherapy, Temozolomide, Doxorubicin: Radiation treatment Concomitant TMZ: 75mg/m2/day per OS for 7 days per week, from the first day of radiotherapy to the last (maximum cumulative dose 3150mg/m2), with possibility of earlier initiation on clinician's judgment. After 1 month (4-5 weeks ± 7 days) from the end of RT/TMZ treatment they will receive: Adjuvant TMZ: 2 cycles at increasing doses (150-180 mg/m2) per OS for 5 consecutive days 28 days apart After 3 months (12 weeks ± 7 days) from the end of RT/TMZ treatment they will receive: Dox 4 cycles with 37.5mg/m2/day by continuous infusion over 48 hours (2 days) every 28 days (maximum cumulative dose 300mg/m2) And after 4 weeks ± 7 days from the end of Dox treatment they will receive: TMZ adjuvant 12 cycles at increasing doses (150-180 mg/m2) by OS for 5 consecutive days 28 days apart (maximum cumulative dose 16200 mg/m2);

Study 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

Eligibility

Primary outcome measure(s)

• Evaluation prolonged Dox — through study completion, an average of 1 year
  Time to early withdrawal from experimental treatment with Dox
• Percentage of Withdrawal from the study rate — through study completion, an average of 1 year
  Percentage of subjects with SAE leading to withdrawal from the study
• Percentage of SAEs — through study completion, an average of 1 year
  Percentage of SAEs
• Mortality rate — through study completion, an average of 1 year
  Mortality from adverse events
• Early discontinuation of dox treatment rate — through study completion, an average of 1 year
  Proportion of early discontinuation of experimental treatment with Dox

Trial sites (1)

Other trials for the same condition