Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma
|ClinicalTrials.gov Identifier: NCT00521482|
Recruitment Status : Unknown
Verified August 2007 by University of Zurich.
Recruitment status was: Not yet recruiting
First Posted : August 28, 2007
Last Update Posted : August 28, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Temozolomide Drug: Temozolomide plus Thalidomide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapy:a Randomized Phase II Trial|
|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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|