Ignite Creation Date:
2024-05-05 @ 9:02 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00807027
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2008-12-10
Brief Title:
Clinical Trial to Assess the Efficacy and Safety of INNOCELL Immuncell-LC With Temozolomide in Newly Diagnosed Glioblastoma of Korea
Sponsor:
GC Cell Corporation
Organization:
GC Cell Corporation
Study Overview
Official Title:
Multi-center Randomized Open-label Phase 3 Clinical Trial to Assess the Efficacy and Safety of INNOCELL Immuncell-LC With Temozolomide in Newly Diagnosed Glioblastoma of Korea
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
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:
This clinical study was planned in order to assess the superiority of INNOCELL Corp Immuncell-LC in aspects of therapeutic efficacy and safety when administered with Temozolomide to glioblastoma patients when compared with the control group who did not receive administration of the drug
Detailed Description:
Primary Purpose Compare clinical efficacy of group treated with cell theraputic INNOCELL Immuncell-LC evaluated by progression free survival with that of untreated group
Secondary Purpose Compare clinical efficacy of group treated with INNOCELL Immuncell-LC a drug for treating glioblastoma evaluated by overall survival therapy reaction EORTC QLQ-C30 and Karnofsky Performance Status KPS and that of untreated group and evaluate adverse reactions clinical pathological tests and its safety
Secondary Purpose Compare clinical efficacy of group treated with INNOCELL Immuncell-LC a drug for treating glioblastoma evaluated by overall survival therapy reaction EORTC QLQ-C30 and Karnofsky Performance Status KPS and that of untreated group and evaluate adverse reactions clinical pathological tests and its safety
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