Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00521482
Status:
UNKNOWN
Last Update Posted:
2007-08-28
First Post:
2007-08-27
Brief Title:
Temozolomide vs Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapya Randomized Phase II Trial
Status:
UNKNOWN
Status Verified Date:
2007-08
Last Known Status:
NOT_YET_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 aim of this study is to evaluate the efficacy and safety of intensive dose temozolomide treatment alone in parallel to a combination with thalidomide in patients with recurrent glioblastoma after standard therapy
In the treatment arm A of the study it will be investigated whether or not continuous dosing of temozolomide may overcome alkylator resistance in patients with glioblastoma who progress on the 528 day dosing regimen
For treatment arm B it is postulated that the combination of thalidomide and temozolomide is effective with respect to time to progression and progression-free survival due to the fact that temozolomide and thalidomide have different mechanisms of action
In the treatment arm A of the study it will be investigated whether or not continuous dosing of temozolomide may overcome alkylator resistance in patients with glioblastoma who progress on the 528 day dosing regimen
For treatment arm B it is postulated that the combination of thalidomide and temozolomide is effective with respect to time to progression and progression-free survival due to the fact that temozolomide and thalidomide have different mechanisms of action
Detailed Description:
Primary objectives To determine the proportion of patients with progression- free survival after 6 months of intensive dose temozolomide treatment alone or in combination with thalidomide in patients with recurrent glioblastoma multiforme after standard therapy
Secondary objectives To assess the effects on tumor growth To determine the time to disease progression To determine the proportion of patients with progression- free survival To assess the safety of intensive dose temozolomide treatment alone or in combination with thalidomide
Explorative evaluations To assess health related Quality of Life To assess cognitive functioning To compare the two treatment arms in terms of efficacy and safety
Secondary objectives To assess the effects on tumor growth To determine the time to disease progression To determine the proportion of patients with progression- free survival To assess the safety of intensive dose temozolomide treatment alone or in combination with thalidomide
Explorative evaluations To assess health related Quality of Life To assess cognitive functioning To compare the two treatment arms in terms of efficacy and 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P04932 | None | None | None |