Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma
Recruitment status was: Not yet recruiting
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 5/28 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.
|Glioblastoma||Drug: Temozolomide Drug: Temozolomide plus Thalidomide||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapy:a Randomized Phase II Trial|
- Proportion of patients with progression free survival [ Time Frame: 6 months ]
- Proportion of patients with a clinical response. Time to disease progression. Progression free survival.
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||January 2009|
Active Comparator: A
Temozolomide 75 mg/m2 daily for 21 days during each 28-day cycle until tumor progression.
Other Name: Temodal
Temozolomide 200 mg/m2 for 5 days during each 28-day cycle plus Thalidomide 100 mg for 2 weeks, thereafter 200 mg daily continuously until tumor progression.
Drug: Temozolomide plus Thalidomide
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521482
|Contact: Miroslava Bjeljac, MD||0041 44 255 23 96||Miroslava.Bjeljac@usz.ch|
|University Zurich, Departement of Neurosurgery||Not yet recruiting|
|Zurich, Switzerland, 8091|
|Principal Investigator: Miroslava Bjeljac, MD|
|Principal Investigator:||Miroslava Bjeljac, MD||University of Zurich|