Newly Diagnosed Non Methylated Glioblastoma Multiforme Grade 4 Clinical Trial
Official title:
Phase 11 Study of Cilengitide in Combination With Concurrent Chemotherapy and Radiotherapy Followed by Protracted Daily Low Dose Temozolomide and Low Dose Procarbazine D1 - 20 in Newly Diagnosed Glioblastoma Without Methylation of the MGMT Promoter Gene
Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months
without interruption.
Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with
concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA
< 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday,
both TMZ and PCB seven days a week).
After a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in
subsequent cycles) and PCB (50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) are then
given daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6
cycles.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment