A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma
- Determine the progression-free survival rate at 6 months in patients with recurrent
glioblastoma multiforme or other malignant glioma treated with temozolomide.
- Determine the overall survival of patients treated with this drug.
- Determine the radiographic response rate in patients treated with this drug.
- Determine the toxicity of this drug in theses patients.
- Determine the event-free survival of patients treated with this drug.
- Determine time to treatment failure.
- Evaluate surrogate markers for neo-angiogenesis to assess whether this mechanism plays
a role in response in patients treated with this drug. (Samples are no longer being
collected and tested as of 1/12/09)
OUTLINE: Patients receive oral temozolomide once daily in the absence of disease progression
or unacceptable toxicity.
Blood samples are collected at baseline and every 2 months for 2 years for evaluation of
markers of neo-angiogenesis. Samples are analyzed by protein expression,
reverse-transcriptase PCR, ELISA, and western blot. (Samples are no longer being collected
and tested as of 1/12/09)
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) rate at 6 months
Antonio Omuro, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|