Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients
with recurrent glioblastoma multiforme or other malignant glioma.
OBJECTIVES:
Primary
- Determine the progression-free survival rate at 6 months in patients with recurrent
glioblastoma multiforme or other malignant glioma treated with temozolomide.
Secondary
- Determine the overall survival of patients treated with this drug.
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)
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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