Glioblastoma Clinical Trial
Official title:
Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapy:a Randomized Phase II Trial
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.
- 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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