Ignite Creation Date:
2024-05-05 @ 9:42 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00944801
Status:
COMPLETED
Last Update Posted:
2009-07-23
First Post:
2009-07-17
Brief Title:
Pegylated Liposomal Doxorubicine and Prolonged Temozolomide in Addition to Radiotherapy in Newly Diagnosed Glioblastoma
Sponsor:
University of Regensburg
Organization:
University of Regensburg
Study Overview
Official Title:
RNOP-09 Pegylated Liposomal Doxorubicine and Prolonged Temozolomide in Addition to Radiotherapy in Newly Diagnosed Glioblastoma - a Phase II Study
Status:
COMPLETED
Status Verified Date:
2009-07
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:
Glioblastomas represent 40 of all tumors of the central nervous system CNS and are among the most lethal tumors Temozolomide TMZ combined with radiotherapy was the first substance to significantly improve the overall survival to 146 months as compared to surgery and radiotherapy alone and increased the proportion of patients surviving more than 2 years to 26 TMZ showed the best efficacy in patients with a methylated O6-methylguanine-DNA methyltransferase MGMT promoter in part by eliminating stem cell-like tumor cells Among patients with a methylated MGMT promoter the median survival after treatment with combined radio-chemotherapy was 217 months as compared to 153 months among those who were assigned to radiotherapy only In the absence of methylation of the MGMT promoter there was a smaller and statistically insignificant difference in survival between the treatment groups
Doxorubicin is one of the most effective substances in vitro against cells derived from glioblastoma However it has no significant effect in vivo due to poor blood-brain-barrier penetration In a tumor model tissue and CSF-concentrations of doxorubicin were substantially increased when sterically stabilized liposomes were used resulting in a comparable clinical response using approximately half of the dose of stabilized liposomes compared to conventional doxorubicin A pegylated formulation PEG-liposomal Doxorubicin even further improved the penetration of the blood-brain barrier Case series and two phase II-studies in patients with recurrent glioblastoma have shown modestly promising results for PEG-Dox
In this study the investigators treated patients with recurrent glioblastoma with 20 mgm2 PEG-Dox on days 1 and 15 of each 28-day cycle To determine the dose limiting toxicity of PEG-Dox combined with prolonged administration of TMZ the investigators performed a phase I part ahead of the phase II study To investigate by means of a historical control analysis if the addition of PEG-Dox to TMZ and radiotherapy improves the survival of patients the investigators chose similar inclusion criteria and identical TMZ and radiotherapeutic regimes as in the EORTC26981NCIC-CE3 study
Doxorubicin is one of the most effective substances in vitro against cells derived from glioblastoma However it has no significant effect in vivo due to poor blood-brain-barrier penetration In a tumor model tissue and CSF-concentrations of doxorubicin were substantially increased when sterically stabilized liposomes were used resulting in a comparable clinical response using approximately half of the dose of stabilized liposomes compared to conventional doxorubicin A pegylated formulation PEG-liposomal Doxorubicin even further improved the penetration of the blood-brain barrier Case series and two phase II-studies in patients with recurrent glioblastoma have shown modestly promising results for PEG-Dox
In this study the investigators treated patients with recurrent glioblastoma with 20 mgm2 PEG-Dox on days 1 and 15 of each 28-day cycle To determine the dose limiting toxicity of PEG-Dox combined with prolonged administration of TMZ the investigators performed a phase I part ahead of the phase II study To investigate by means of a historical control analysis if the addition of PEG-Dox to TMZ and radiotherapy improves the survival of patients the investigators chose similar inclusion criteria and identical TMZ and radiotherapeutic regimes as in the EORTC26981NCIC-CE3 study
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