Pegylated Liposomal Doxorubicine and Prolonged Temozolomide in Addition to Radiotherapy in Newly Diagnosed Glioblastoma
Glioblastoma
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring glioblastoma, first-line, clinical trial, PEG-liposomal doxorubicin, temozolomide, radiotherapy, phase 1, phase 2
Eligibility Criteria
Inclusion Criteria:
- newly diagnosed glioblastoma
- centrally confirmed histology
- Karnofsky performance score (KPS) > 70%
- stable corticosteroids within 2 weeks before inclusion
- leucocytes > 3/ul, thrombocytes > 100/ul, Hb > 10 g/dl
- additional standard criteria
Exclusion Criteria:
- other tumor in history
- pretreatment with radiotherapy to the brain
Sites / Locations
- University of Regensburg, Department of Neurology
Arms of the Study
Arm 1
Experimental
Pegylated Liposomal Doxorubicin
Radiotherapy is planned with dedicated computed tomography and three-dimensional planning systems and delivered to the gross tumor volume with a 2 to 3 cm margin for the clinical target volume. After a 4-week break, patients receive adjuvant TMZ 150 to 200 mg/m2 day 1 to 5 in 28 days until tumor progression or up to at least 12 cycles. In the dose escalation phase of the study, PEG-Dox is raised in steps of 5 mg/m2 in a 3-by-3 design, starting with 5 mg/m2 (group 1) up to 20 mg/m2 (group 4). In the phase II part of the study, the targeted dose of 20 mg/m2 is administered up to a cumulative dose of 550 mg/m2 or until tumor progression.