Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapy:a Randomized Phase II Trial
- 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with progression free survival
6 months
Miroslava Bjeljac, MD
Principal Investigator
University of Zurich
Switzerland: Swissmedic
TMZ/05
NCT00521482
September 2007
January 2009
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