Ignite Creation Date:
2024-05-06 @ 1:06 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01737346
Status:
UNKNOWN
Last Update Posted:
2012-12-03
First Post:
2012-11-27
Brief Title:
Procarbazine and Lomustine in Recurrent Glioblastoma
Sponsor:
Incheon StMarys Hospital
Organization:
Incheon StMarys Hospital
Study Overview
Official Title:
Phase 2 Clinical Trial of PCProcarbazine-CCNU Chemotherapy in Patients With Recurrent or Resistant Glioblastoma With Methylated MGMT
Status:
UNKNOWN
Status Verified Date:
2012-11
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:
None
Brief Summary:
The combination therapy of temozolomide and radiation has been established as the standard therapy for the initial treatment of glioblastoma However the prognosis for patients with recurrent refractory glioblastoma is dismal with a median survival of 36 months There is no efficient and standard care at the time of recurrence or progression following temozolomide administration Recently many clinicians have reassessed the efficacy of second-line chemotherapeutic agents such as nitrosoureas for the treatment of recurrentrefractory glioblastoma It is very important that the effect of the agent is sustained and the adverse effect is reduced to preserve the quality of life in recurrent settings We have realized that the clinical features of Korean patients are very different from those of foreign patients Therefore it is mandatory to develop the new strategy for the treatment of Korean patients We modify the PCV chemotherapy in the dose and administration schedule of CCNU and procarbazine to reduce the side effect especially hematologic problems The dose of CCNU is reduced to 75mgm2 and the interval between CCNU and procarbazine is increased Moreover vincristine is excluded because BBB permeability of vincristine is very poor and the risk of neurotoxicity is high We introduce the modified PC chemotherapy regimen for the treatment of recurrentrefractory glioblastoma which is the first multicenter trial for glioblastoma patients in Korea
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