drugset / Trial / NCT01124240
Temozolomide and Procarbazine With Cilengitide for Patients With Glioblastoma Multiforme Without Methylation of the MGMT Promoter Gene
Phase 2
Unknown
48 enrolled
Northern Sydney and Central Coast Area Health Service
Merck KGaA, Darmstadt, Germany · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2009-11
- Primary completion
- 2012-11
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Temozolomide | Small molecule | 60 mg/m2 | Oral |
| Subject | cilengitide | Peptide | 2000 mg | Intravenous |
| Subject | procarbazine | Small molecule | 50 mg | Oral |
| Subject | procarbazine | Small molecule | 100 mg | Oral |