Ignite Creation Date:
2024-05-05 @ 10:31 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01124240
Status:
UNKNOWN
Last Update Posted:
2011-07-26
First Post:
2010-05-13
Brief Title:
Temozolomide and Procarbazine With Cilengitide for Patients With Glioblastoma Multiforme Without Methylation of the MGMT Promoter Gene
Sponsor:
Northern Sydney and Central Coast Area Health Service
Organization:
Northern Sydney and Central Coast Area Health Service
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2011-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ExCentric
Brief Summary:
Cilengitide 2000 mg flat iv 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 mgm2 po and daily procarbazine PCB 50 mg po if BSA 17 100 mg po if BSA 17 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 50mgm2 po in first cycle 60 mgm2 po in subsequent cycles and PCB 50 mg po if BSA 17 100 mg po if BSA 17 are then given daily D1 to 20 This TMZPCB cycle is repeated every 28 days over a total period of 6 cycles
Starting one week after the initiation of Cilengitide RTX 60 Gy 2 Gy per fraction with concurrent daily temozolomide 60 mgm2 po and daily procarbazine PCB 50 mg po if BSA 17 100 mg po if BSA 17 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 50mgm2 po in first cycle 60 mgm2 po in subsequent cycles and PCB 50 mg po if BSA 17 100 mg po if BSA 17 are then given daily D1 to 20 This TMZPCB cycle is repeated every 28 days over a total period of 6 cycles
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None