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.
Primary Outcome Measures:
- Progression-free survival (PFS) rate at 6 months [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
- Overall response rate [ Designated as safety issue: No ]
- PFS [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: |
47 |
| Study Start Date: |
June 2007 |
| Estimated Primary Completion Date: |
December 2008 (Final data collection date for primary outcome measure) |
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.
- 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.
Tertiary
- Evaluate surrogate markers for neo-angiogenesis to assess whether this mechanism plays a role in response in 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.
Purpose
